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Hydrocortisone

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Active ingredient
Hydrocortisone .284 g/287.4 g – 1 h/100 g
Reference brand
Hemorrodil Unguento Plus
Drug class
Corticosteroid
Dosage forms
  • Aerosol, Spray
  • Cream
  • Gel
  • Lipstick
  • Liquid
  • Lotion
  • Ointment
  • Shampoo
  • Solution
  • Spray
  • Stick
Routes
  • Rectal
  • Topical
Prescription status
OTC (over the counter)
Marketed in the U.S.
Since 1964
Label revision date
March 18, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Active ingredient
Hydrocortisone .284 g/287.4 g – 1 h/100 g
Reference brand
Hemorrodil Unguento Plus
Drug class
Corticosteroid
Dosage forms
  • Aerosol, Spray
  • Cream
  • Gel
  • Lipstick
  • Liquid
  • Lotion
  • Ointment
  • Shampoo
  • Solution
  • Spray
  • Stick
Routes
  • Rectal
  • Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Marketed in the U.S.
Since 1964
Label revision date
March 18, 2026
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Product Labels (426)
Product Labels (426)

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Drug Overview

Hydrocortisone is a topical cream that contains 1% hydrocortisone, an anti-itch medication designed to provide temporary relief from itching associated with minor skin irritations, inflammation, and rashes. It is effective for various conditions, including eczema, psoriasis, insect bites, poison ivy, poison oak, and reactions to soaps, detergents, cosmetics, and jewelry. This cream can also relieve external anal and genital itching.

When applied to the affected area, hydrocortisone works by reducing inflammation and soothing the skin, helping to alleviate discomfort. It is important to use this product as directed and consult a healthcare professional for any other uses or if symptoms persist.

Uses

You can use this product to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes caused by various conditions such as eczema, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac. It is also effective for alleviating itching from soaps, detergents, cosmetics, and jewelry. Additionally, this product can provide relief for external anal and genital itching.

For best results, apply the product to the affected area as directed, and consult a doctor for any other uses or if symptoms persist. Always follow the advice of a healthcare professional, especially for children under 2 years of age.

Dosage and Administration

For treating itching due to skin irritation, inflammation, or rashes, you can apply the cream or ointment to the affected area up to 3 to 4 times daily if you are an adult or a child aged 2 years and older. If you are under 2 years old, do not use the product without consulting a doctor.

For external anal and genital itching, adults should first clean the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting with toilet tissue or a soft cloth before applying the product. This should also be done up to 3 to 4 times daily. Children under 12 years of age should consult a doctor before use for this purpose.

What to Avoid

You should avoid using this product if you have a vaginal discharge, as it may require consultation with a doctor. Additionally, do not use it for the treatment of diaper rash without consulting a healthcare professional. It's important to avoid contact with your eyes and not to exceed the recommended dosage unless directed by a doctor. Never apply this product directly into the rectum using fingers or any mechanical device or applicator. If your condition worsens, persists for more than 7 days, or clears up and then reoccurs, seek medical advice. If rectal bleeding occurs, stop using the product and consult a doctor.

Side Effects

When using hydrocortisone products, it's important to be aware of potential side effects and warnings. These products are for external use only and should not be applied in the eyes or used for diaper rash without consulting a doctor. You should avoid using them in the genital area if you have a vaginal discharge.

Stop using the product and consult a doctor if your condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then return within a few days. Additionally, if you experience rectal bleeding, seek medical advice promptly. Always keep these products out of reach of children, and if swallowed, contact a Poison Control Center immediately.

Warnings and Precautions

For your safety, this product is for external use only. Avoid contact with your eyes, and do not use it in the genital area if you have a vaginal discharge or for the treatment of diaper rash—consult a doctor in these cases.

You should stop using the product and consult a doctor if:

  • Your condition worsens.

  • Symptoms persist for more than 7 days or clear up and then return within a few days.

  • You experience rectal bleeding.

If you accidentally swallow the product, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. Keep this product out of reach of children.

Always follow the recommended dosage and do not use this or any other hydrocortisone product unless directed by a doctor.

Overdose

If you accidentally swallow a product containing hydrocortisone or an anti-itch cream, it's important to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Signs of an overdose may include severe skin irritation or other serious side effects. Always keep these products out of reach of children to prevent accidental ingestion. If you notice any unusual symptoms after swallowing, do not hesitate to get professional assistance.

Pregnancy Use

If you are pregnant or breastfeeding, it is important to consult a healthcare professional before using hydrocortisone products, including creams, ointments, and sprays. The safety of hydrocortisone during pregnancy has not been established, and there may be potential risks to the fetus. Use these products only if clearly needed and under the guidance of a healthcare provider, as dosage adjustments may be necessary.

While some products do not specify contraindications or risks, caution is advised. Always weigh the potential benefits against the risks before use, and seek medical advice if you have any concerns.

Lactation Use

You may be considering the use of hydrocortisone products while breastfeeding. Most labels indicate that there are no specific warnings or recommendations for nursing mothers. However, some products do mention a potential for excretion in breast milk, meaning that the ingredients could pass into your milk. Caution is advised, especially since the effects on nursing infants are not well studied. It is generally recommended to consult a healthcare professional before using any hydrocortisone products while breastfeeding to ensure safety for both you and your baby.

If you choose to use these products, monitor your infant for any adverse reactions. Always prioritize open communication with your healthcare provider regarding any medications or treatments during lactation.

Pediatric Use

For children under 2 years of age, most hydrocortisone products should not be used without consulting a doctor. If your child is 2 years or older, you can apply the product to the affected area up to 3 to 4 times daily. However, for children under 12 years of age, it's important to consult a doctor before using these products for external anal and genital itching.

Always keep these products out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Geriatric Use

You may find that many hydrocortisone products, including creams, ointments, and sprays, do not have specific information regarding their use in older adults. This means there are no established dosage adjustments, safety concerns, or special precautions outlined for elderly patients.

When using hydrocortisone products, it's important to apply them as directed on the label. If you have any underlying health conditions or are taking other medications, consult your healthcare provider before use to ensure safety and effectiveness. Always monitor for any unusual reactions, especially if you are using these products for the first time.

Renal Impairment

When using hydrocortisone products, it's important to be aware of how kidney health can affect your treatment. For patients with renal impairment, dosage adjustments may be necessary, especially if your creatinine clearance is less than 30 mL/min. Regular monitoring of renal function tests is recommended to ensure your kidneys are handling the medication appropriately.

If you have known kidney problems, consult your healthcare provider before starting any hydrocortisone treatment to discuss the best approach for your specific situation. Most hydrocortisone products do not provide specific guidelines for renal impairment, so it's crucial to take proactive steps in managing your health.

Hepatic Impairment

You may be wondering about the use of various anti-itch creams and hydrocortisone products if you have liver issues. It's important to note that many of these products do not provide specific information regarding liver impairment, dosage adjustments, or monitoring requirements. This means that if you have liver problems, there are no established guidelines for how these medications should be used in your case.

However, one product, Hydrocortisone lotion, indicates that hepatic impairment may affect how the drug is processed in your body. For this product, dosage adjustments might be necessary, and monitoring of liver function tests is recommended. If you have liver concerns, it's best to consult with your healthcare provider before using any of these products to ensure your safety and proper management of your condition.

Drug Interactions

Most hydrocortisone products, including creams, ointments, and sprays, do not have any specific drug interactions or laboratory test interactions reported. However, it is important to note that you should not use any other hydrocortisone product simultaneously without consulting your healthcare provider. This is crucial because combining medications can lead to unexpected side effects or reduced effectiveness.

Always discuss your medications and any treatments you are considering with your healthcare provider to ensure they are safe and appropriate for your individual health needs.

Storage and Handling

To ensure the effectiveness and safety of your anti-itch products, store them at a controlled room temperature between 20°C to 25°C (68°F to 77°F). Avoid exposing them to excessive heat (above 30°C or 86°F) or freezing conditions, as this can compromise their quality. Always keep the containers tightly closed when not in use and protect them from light and humidity.

Before using any product, check the packaging for a tamper-evident seal. If the seal is broken or damaged, do not use the product. Additionally, be sure to note the lot number and expiration date, which can typically be found on the box or crimp of the tube. For disposal, discard any opened products after use, and do not flush them down the toilet. Always keep these products out of reach of children.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to various conditions, including:

  • Eczema

  • Psoriasis

  • Poison Ivy, Oak, and Sumac

  • Insect Bites

  • Detergents

  • Jewelry

  • Cosmetics

  • Soaps

  • Seborrheic Dermatitis

Additionally, this drug is indicated for the temporary relief of external anal and genital itching.

Other uses of this product should only be under the advice and supervision of a doctor.

Limitations of Use

  • For children under 2 years of age, consultation with a doctor is advised before use.

  • For children under 12 years of age, it is recommended to seek a doctor's advice prior to application.

  • The product should not be used for more than 7 days unless directed by a healthcare professional.

Dosage and Administration

Adults and children 2 years of age and older are instructed to apply the product to the affected area not more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor before use.

For external anal and genital itching in adults, it is recommended to clean the affected area with mild soap and warm water when practical, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before applying the product. This application should also not exceed 3 to 4 times daily. For children under 12 years of age experiencing external anal itching, consultation with a doctor is necessary.

Healthcare professionals should ensure that patients are aware of the importance of not exceeding the recommended frequency of application and to avoid contact with eyes. If symptoms persist or worsen, patients should seek medical advice.

Contraindications

Do not use in the genital area if there is a vaginal discharge; consult a doctor. The product is contraindicated for the treatment of diaper rash; consult a doctor before use. Avoid using this product with any other hydrocortisone product unless directed by a doctor. Additionally, do not apply this product directly into the rectum using fingers or any mechanical device or applicator.

Contact with the eyes should be avoided. If rectal bleeding occurs, or if the condition worsens or persists for more than 7 days, discontinue use and consult a doctor.

Warnings and Precautions

For external use only.

Do Not Use

  • In the genital area if you have a vaginal discharge. Consult a doctor.

  • For the treatment of diaper rash. Consult a doctor.

  • If you are allergic to any ingredient in this product.

When Using This Product

  • Avoid contact with the eyes. If contact occurs, rinse thoroughly with water.

  • Do not use more than directed unless told to do so by a doctor.

  • Do not put directly into the rectum by using fingers or any mechanical device or applicator.

  • For external anal itching, do not exceed the recommended daily dosage unless directed by a doctor.

Stop Use and Ask a Doctor If

  • Condition worsens.

  • Symptoms persist for more than 7 days or clear up and occur again within a few days.

  • Rectal bleeding occurs. Consult a doctor promptly.

  • You experience excessive irritation of the skin.

General Precautions

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

  • If pregnant or breastfeeding, ask a health professional before use.

  • Contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120°F.

  • Flammable: Keep away from fire or flame.

Get Emergency Medical Help

  • If swallowed, get medical help or contact a Poison Control Center immediately.

Side Effects

Patients using hydrocortisone products should be aware of the following adverse reactions and warnings associated with their use:

Warnings

  • For external use only.

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.

  • Do not use in the genital area if there is a vaginal discharge; consult a doctor.

  • Do not use for the treatment of diaper rash; consult a doctor.

  • Do not put this product into the rectum using fingers or any mechanical device or applicator.

  • Flammable; keep away from fire or flame.

Stop Use and Ask a Doctor If

  • Condition worsens.

  • Symptoms persist for more than 7 days or clear up and occur again within a few days.

  • Rectal bleeding occurs; consult a doctor promptly.

  • If using any other hydrocortisone product, consult a doctor before use.

Additional Adverse Reactions or Important Notes

  • If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

  • Keep out of reach of children.

  • In case of excessive irritation or burning sensation at the site of application, discontinue use and consult a doctor.

Specific Considerations

  • For external anal itching, do not exceed the recommended daily dosage unless directed by a doctor.

  • Consult a doctor before using on children under 2 years of age or if pregnant or breastfeeding.

Patients should be vigilant for any signs of adverse reactions and seek medical advice if any of the above conditions occur.

Drug Interactions

The available data on drug interactions for various hydrocortisone products indicates a lack of specific interactions across multiple formulations.

Hydrocortisone Products

  • General Findings: Most hydrocortisone products, including ointments, creams, sprays, and lotions, do not report any drug interactions or laboratory test interactions. This includes well-known brands such as Hydrocortisone, Cortizone 10, and Equate Cortisone, among others.

  • Specific Note: The product labeled as "Medi-First Hydrocortisone, Medi-First Plus Hydrocortisone" includes a caution against using it with any other hydrocortisone product unless a doctor has been consulted. This is the only mention of a potential interaction within the reviewed labels.

Summary

Overall, the reviewed hydrocortisone products do not present significant drug interaction concerns, with the exception of the noted caution regarding concurrent use of multiple hydrocortisone formulations. Users are advised to consult healthcare professionals for personalized advice, especially when considering the use of multiple topical treatments.

Pediatric Use

Pediatric patients under 2 years of age should not use hydrocortisone products without consulting a doctor. For children aged 2 years and older, hydrocortisone can be applied to the affected area not more than 3 to 4 times daily.

Efficacy and Safety

  • Children under 2 years of age:

    • Do not use without consulting a doctor.

  • Children 2 years of age and older:

    • Apply to the affected area not more than 3 to 4 times daily.

    • For external anal and genital itching, consult a doctor if the child is under 12 years of age.

Dosage Recommendations

  • For itching of skin irritation, inflammation, and rashes:

    • Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

  • For external anal and genital itching:

    • Adults: apply to the affected area not more than 3 to 4 times daily after cleansing.

    • Children under 12 years of age: consult a doctor before use.

Cautions

  • Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

  • Consult a doctor for any use in children under 2 years of age or for external anal itching in children under 12 years of age.

Geriatric Use

No specific information regarding geriatric use, dosage adjustments, safety concerns, or special precautions for elderly patients is provided in the inserts for the various hydrocortisone formulations, including creams, ointments, sprays, and lotions. As such, healthcare professionals should exercise caution when prescribing these products to geriatric patients, considering the lack of data on their safety and efficacy in this population. Regular monitoring for potential adverse effects is recommended, and clinicians may need to adjust treatment based on individual patient responses and tolerability.

Pregnancy

The safety of hydrocortisone products during pregnancy has not been established. Pregnant patients are advised to consult a healthcare professional before using any hydrocortisone formulations, including creams, ointments, and sprays.

While some products do not specify contraindications or risks to the fetus, caution is generally recommended. Potential risks to the fetus are not clearly defined, and the use of hydrocortisone should only occur if the benefits outweigh the risks. Dosage adjustments may be necessary, and healthcare providers should be consulted for guidance tailored to pregnant individuals.

Specific precautions include using hydrocortisone only if clearly needed and under medical supervision. Pregnant patients should refrain from using hydrocortisone products without prior consultation, especially if they are planning to become pregnant or are breastfeeding.

Lactation

There are limited specific warnings or recommendations regarding the use of hydrocortisone products in nursing mothers across various formulations, including creams, ointments, and sprays. Most products do not provide information on the potential for excretion in breast milk or associated risks to breastfed infants.

However, some products indicate a potential for excretion in breast milk and advise caution. For instance, nursing mothers are encouraged to consult a healthcare professional before using hydrocortisone products, particularly those that explicitly mention the possibility of excretion in breast milk. The effects on nursing infants have not been well studied, and monitoring for any adverse reactions is recommended.

In summary, while many hydrocortisone products lack specific lactation-related data, caution is advised when used by nursing mothers, especially for those formulations that indicate potential excretion in breast milk. It is prudent for lactating mothers to consult healthcare professionals before use to weigh the risks and benefits.

Renal Impairment

Patients with renal impairment may require careful consideration when using certain hydrocortisone products. For some formulations, dosage adjustments may be necessary, particularly for those with reduced renal function. It is recommended that renal function tests be conducted regularly for patients with known kidney issues to monitor their condition effectively.

Specifically, for patients with a creatinine clearance of less than 30 mL/min, a reduced dose should be considered to mitigate the risk of potential toxicity. Special monitoring is also advised for patients with significant renal impairment to ensure their safety and the efficacy of the treatment.

While many hydrocortisone products do not provide specific guidance regarding renal impairment, those that do emphasize the importance of assessing renal function prior to initiating therapy and periodically thereafter. This approach helps to tailor treatment to the individual needs of patients with compromised kidney function.

Hepatic Impairment

Patients with hepatic impairment may experience altered metabolism of the drug. Therefore, dosage adjustments may be necessary for this population. It is recommended to monitor liver function tests in patients with hepatic impairment to ensure safety and efficacy. Special precautions should be taken when administering the drug to patients with liver problems, although specific dosage adjustments, monitoring requirements, or additional precautions are not detailed in the drug inserts for the majority of products reviewed.

Overdosage

In the event of an overdose, immediate medical assistance should be sought by contacting a Poison Control Center or a healthcare professional. The contact number for the Poison Control Center is 1-800-222-1222.

Symptoms of overdose may include severe skin irritation or other serious side effects. It is crucial to monitor for any adverse reactions following ingestion. If the product is swallowed, individuals should be advised to seek medical help promptly.

Additionally, it is important to keep all medications out of the reach of children to prevent accidental ingestion. In cases where the recommended dosage has been exceeded, or if there are any concerns regarding the use of the product, consulting a healthcare provider is strongly recommended.

Nonclinical Toxicology

Teratogenic Effects

In animal studies, no teratogenic effects were observed with the use of hydrocortisone formulations. Specifically, no increase in fetal malformations was noted in these studies.

Non-Teratogenic Effects

The available data indicate that there are no specified non-teratogenic effects associated with hydrocortisone products.

Impairment of Fertility

There is no information provided regarding the effects of hydrocortisone on fertility.

Carcinogenesis and Mutagenesis

No information is available concerning the carcinogenic or mutagenic potential of hydrocortisone formulations.

General Animal Toxicology

The nonclinical toxicology section does not provide specific details regarding animal pharmacology and toxicology for hydrocortisone products. Additionally, there are no specified animal studies or toxicological data available in the provided information.

Special Population Considerations

For individuals who are pregnant or breastfeeding, it is advised to consult a health professional before using hydrocortisone products.

Storage and Handling

Products are supplied in various forms including creams, ointments, sprays, gels, and lotions. The storage conditions for these products generally recommend maintaining a controlled room temperature between 20° to 25°C (68° to 77°F). Some products may have specific instructions to avoid temperatures exceeding 30°C (86°F) or to protect from freezing.

Storage Conditions

  • General Storage: Most products should be stored at room temperature, specifically between 20° to 25°C (68° to 77°F).

  • Temperature Limits: Certain products must not exceed 30°C (86°F) and should be protected from freezing.

  • Specific Instructions:

    • Products in aerosol or spray forms should not be stored above 120°F and must be kept away from heat, sparks, and open flames.

    • Some products require protection from light and should be kept tightly closed when not in use.

Handling Requirements

  • Tamper Evident: Many products are tamper-evident; do not use if the seal is broken or missing.

  • Expiration Information: Users should check the carton or tube crimp for lot numbers and expiration dates.

  • Child Safety: Keep out of reach of children and discard any opened or unused products after a specified period.

Additional Notes

  • For products that require shaking before use, it is important to follow this instruction to ensure proper consistency.

  • If any product's seal has been broken, it should not be used and should be returned to the place of purchase.

These guidelines ensure the efficacy and safety of the products throughout their shelf life.

Product Labels

The table below lists all over-the-counter labels containing hydrocortisone. Use it to compare dosage forms, strengths, and uses across products.

FDA-Approved Hydrocortisone Labels (Originator & Generics) showing branded and generic formulations with forms, routes, strengths, and FDA approval years.
More Details

Repacked & Relabeled Product Labels

The table below lists products marketed under repackaged or relabeled National Drug Codes (NDCs).

Only the carton or labeler has changed; the underlying SPL and prescribing information match the primary labels above, so no separate detail pages are provided.

Below are the non-prescription pack sizes of Anti Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

FDA-Approved Hydrocortisone Repack / Relabels showing repack and relabel formulations with forms, routes, strengths, and FDA years.
Label
Forms
Routes
Hydrocortisone
FDA year
Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It consolidates data from 426 FDA Structured Product Labels (DailyMed) for Hydrocortisone (marketed as Anti Itch, Quality Choice Anti Itch with Aloe, Theracare Hydrocortisone Cream), with data retrieved by a validated AI data-extraction workflow. This includes 426 distinct product formulations. All FDA-listed dosage forms and strengths are aggregated in the sections above. Regulatory status appears in the Summary Information panel and was verified in the FDA National Drug Code directory. Detailed product-specific information is available via the individual label pages linked above. No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.