Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Hydrocortisone

Last content change checked dailysee data sync status

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
February 7, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2010
Label revision date
February 7, 2024
Manufacturer
Safetec of America, Inc.
Registration number
M017
NDC root
61010-5800
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

1% Hydrocortisone Cream™ is a topical medication designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It can be helpful for conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, jewelry, as well as seborrheic dermatitis and psoriasis.

This cream works by reducing inflammation and alleviating discomfort in the affected areas. While it is effective for these common skin issues, it's important to use it as directed and consult a doctor for any other uses.

Uses

You can use this product for the temporary relief of itching caused by minor skin irritations, inflammation, and rashes. This includes conditions related to eczema, insect bites, poison ivy, poison oak, poison sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

If you or your child is experiencing discomfort from external anal itching, here's how to use the medication effectively. For adults and children aged 2 years and older, you should apply the product to the affected area 3 to 4 times a day. However, if your child is under 2 years old, it's important not to use this medication without first consulting a doctor.

For adults specifically dealing with external anal itching, it's best to start by gently cleansing the affected area with mild soap and warm water. Make sure to rinse thoroughly and then dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the product. If the user is a child under 12 years old, please consult a doctor for guidance on how to proceed.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash, in your eyes, or for feminine itching. If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using it and consult your doctor. Additionally, avoid using this product alongside any other Hydrocortisone product unless you have discussed it with your healthcare provider. Always prioritize your health and safety by following these guidelines.

Side Effects

This product is intended for external use only. You should not use it for treating diaper rash, in your eyes, or for feminine itching. If your condition worsens, lasts more than 7 days, or clears up and then comes back within a few days, stop using it. Additionally, avoid using it with any other Hydrocortisone product unless you have consulted a doctor.

It's important to keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only. You should not use it for treating diaper rash, applying it in your eyes, or for feminine itching. If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and call your doctor. Additionally, avoid using it alongside any other Hydrocortisone product unless you have consulted with a healthcare professional.

Make sure to keep this product out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned about using hydrocortisone cream during pregnancy. This means that the drug insert does not provide information on whether you need to adjust the dosage or take special precautions while using this cream.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding and considering the use of hydrocortisone cream, you can feel reassured that there are no specific warnings or recommendations against its use for nursing mothers. Additionally, the information available does not indicate any concerns about the cream being passed into breast milk or posing a risk to your infant.

As always, it's a good idea to consult with your healthcare provider if you have any questions or concerns about using any medication while breastfeeding.

Pediatric Use

If you have a child aged 2 years or older, you can apply the medication to the affected area 3 to 4 times a day. However, if your child is under 2 years old, it's important not to use this medication without first consulting a doctor. Additionally, for children under 12 years who are experiencing external anal itching, you should also seek advice from a doctor before using the product. Always prioritize your child's safety and well-being by following these guidelines.

Geriatric Use

While there is no specific information about the use of Hydrocortisone cream in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare provider before using this cream. They can help determine if it’s appropriate for you or your loved one, considering any unique health needs or conditions. Always prioritize safety and seek professional advice when introducing new medications.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication should be used if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to be cautious when using hydrocortisone. You should not use it alongside any other hydrocortisone products unless you have first consulted with your healthcare provider. This is crucial because combining these medications can lead to unwanted side effects or complications.

Always discuss any medications you are taking with your doctor, including over-the-counter products, to ensure your safety and the effectiveness of your treatment. Your healthcare provider can help you understand the best way to manage your medications.

Storage and Handling

To ensure the best performance and safety of your product, store it at room temperature and avoid freezing. It's important to keep the product in its original packaging until you're ready to use it. If you notice any opened or torn packets, do not use them, as this could compromise the product's effectiveness and safety. Always handle the product with care to maintain its integrity.

Additional Information

You should apply this medication topically to the affected area 3 to 4 times daily if you are an adult or a child aged 2 years and older. If your child is under 2 years old, do not use this medication without consulting a doctor first. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is 1% Hydrocortisone Cream used for?

1% Hydrocortisone Cream is used for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

Who should use 1% Hydrocortisone Cream?

It is intended for adults and children 2 years of age and older. Children under 2 years of age should not use it without consulting a doctor.

How often should I apply 1% Hydrocortisone Cream?

You should apply it to the affected area 3 to 4 times daily.

Are there any contraindications for using this cream?

Yes, do not use it for diaper rash, in the eyes, for feminine itching, or if the condition worsens or lasts more than 7 days.

What should I do if I swallow 1% Hydrocortisone Cream?

If swallowed, get medical help or contact a Poison Control Center right away.

Can I use 1% Hydrocortisone Cream with other hydrocortisone products?

You should not use it with any other hydrocortisone product unless you have consulted a doctor.

Is there any information about using this cream during pregnancy or while nursing?

The insert does not provide specific information regarding the use of hydrocortisone cream during pregnancy or lactation.

How should I store 1% Hydrocortisone Cream?

Store it at room temperature and do not freeze. Also, do not use any opened or torn packets.

Packaging Info

Below are the non-prescription pack sizes of Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Drug Information (PDF)

This file contains official product information for Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

1% Hydrocortisone Cream™ contains hydrocortisone as the active ingredient at a strength of 1%. This formulation is presented in a cream dosage form and is packaged in a size of 0.9 g (1/32 oz.). The product is manufactured by Safetec of America, Inc., located in Buffalo, NY 14215. For inquiries, the contact number is 800-456-7077.

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, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For adults and children aged 2 years and older, the recommended application frequency is 3 to 4 times daily to the affected area. Prior to application, adults experiencing external anal itching should cleanse the affected area with mild soap and warm water, ensuring thorough rinsing. Alternatively, the area may be cleansed by patting or blotting with an appropriate cleansing pad. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age experiencing external anal itching, it is advised to consult a doctor prior to use.

Contraindications

The product is contraindicated in the following situations:

  • The treatment of diaper rash is not recommended.

  • Application in or around the eyes is prohibited.

  • The product should not be used for feminine itching.

  • Use is contraindicated if the condition worsens or persists for more than 7 days, or if symptoms resolve and recur within a few days.

  • Concurrent use with any other Hydrocortisone product is not advised unless a healthcare professional has been consulted.

Warnings and Precautions

For external use only. This product is contraindicated for the treatment of diaper rash and should not be applied in or around the eyes. It is also not intended for use in cases of feminine itching.

Healthcare professionals should advise patients to discontinue use if the condition worsens or persists for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should be cautioned against using this product in conjunction with any other Hydrocortisone products without prior consultation with a healthcare provider.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that the product is intended for external use only. It is contraindicated for the treatment of diaper rash, application in the eyes, and for feminine itching. Additionally, the product should not be used if the condition worsens or persists for more than 7 days, or if it clears up and recurs within a few days. It is also advised not to use this product in conjunction with any other Hydrocortisone product without prior consultation with a healthcare professional.

In the event of accidental ingestion, it is crucial to keep the product out of reach of children. If swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Interactions

Co-administration of this product with other Hydrocortisone formulations is contraindicated unless a healthcare professional has been consulted. This precaution is essential to avoid potential additive effects and complications associated with excessive corticosteroid exposure. Monitoring for signs of corticosteroid-related adverse effects is advised if such combinations are deemed necessary by a healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area 3 to 4 times daily. For children under 2 years of age, the medication is not recommended, and a consultation with a doctor is advised. Additionally, for children under 12 years of age experiencing external anal itching, it is important to consult a doctor before use.

Geriatric Use

There is no specific information regarding the use of Hydrocortisone cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

There are no specific statements regarding the use of hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or special precautions. As such, healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of discussing any medications with their healthcare provider prior to use during pregnancy.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, the prescribing information does not provide statements concerning the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants. Therefore, healthcare professionals may consider the use of hydrocortisone cream in nursing mothers on a case-by-case basis, while remaining aware of the absence of specific data on this topic.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical intervention is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical assistance or contact a Poison Control Center without delay.

Prompt action is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended to ensure patient safety and effective resolution of any complications arising from the overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question. Further studies may be necessary to elucidate these aspects of nonclinical toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients that in the event of accidental ingestion, it is crucial to seek medical assistance immediately or contact a Poison Control Center. This prompt action is essential to ensure the safety and well-being of the patient.

Storage and Handling

The product is supplied in packets that must be stored at room temperature. It is essential to avoid freezing the product to maintain its integrity. Healthcare professionals should ensure that any opened or torn packets are not used, as this may compromise the quality and safety of the product.

Additional Clinical Information

The product is administered topically, with a recommended application frequency of 3 to 4 times daily for adults and children aged 2 years and older. For children under 2 years of age, it is advised to consult a doctor before use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Hydrocortisone, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Hydrocortisone, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

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.