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Equate Hydrocortisone

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Active ingredient
Hydrocortisone 1 g/100 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 1995
Label revision date
July 14, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 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 1995
Label revision date
July 14, 2025
Manufacturer
Wal-Mart Stores Inc.
Registration number
M017
NDC root
49035-973
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

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

Hydrocortisone Cream 1% is a topical medication designed to provide maximum strength relief for various skin irritations. It works as an antipruritic (anti-itch) agent, helping to temporarily relieve itching caused by conditions such as eczema, psoriasis, poison ivy, insect bites, and other minor skin irritations. This cream is enriched with healing moisturizers and vitamins A, D, and E, along with antioxidants and chamomile, which can help soothe and nourish the skin.

In addition to its use for general skin irritations, Hydrocortisone Cream 1% can also temporarily relieve external anal and genital itching. While it is effective for these purposes, it's important to use it under the advice and supervision of a doctor for any other uses.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions like eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can relieve external itching in the anal and genital areas. For any other uses, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 to 4 times a day. This is suitable for adults and children who are 2 years old and older. However, if your child is under 2 years of age, it's best to consult a doctor before use.

For external itching around the anal and genital areas in adults, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. After cleaning, pat or blot the area dry with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely and effectively. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash—please consult your doctor in these cases. Additionally, avoid using this product if you experience rectal bleeding or if your condition worsens, persists for more than 7 days, or clears up only to return shortly after. Always check with your doctor before starting any other hydrocortisone product.

While using this product, be careful to avoid contact with your eyes, and do not exceed the recommended dosage unless directed by your doctor. Never insert the product directly into the rectum using your fingers or any device. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If you experience worsening symptoms, if your condition persists for more than 7 days, or if you notice rectal bleeding, stop using the product and consult a doctor. Additionally, do not use this product in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a healthcare professional.

If the product is swallowed, seek medical help or contact a Poison Control Center immediately. Remember, this product is for external use only.

Warnings and Precautions

This product is for external use only, so please avoid applying it to the genital area if you have a vaginal discharge or for treating diaper rash—consult your doctor in these cases. Be careful to keep it away from your eyes, and do not use more than the recommended amount unless your doctor advises otherwise. It's important not to insert the product directly into the rectum using fingers or any devices.

If your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, stop use immediately and seek medical advice. Always keep this product out of reach of children, and if it is swallowed, get medical help or contact a Poison Control Center right away.

Overdose

If you or someone else has swallowed too much of a 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. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of hydrocortisone during pregnancy has not been established. There may be potential risks to your fetus, so it's crucial to consult your healthcare provider before using this medication. They can help determine if hydrocortisone is appropriate for you and may recommend dosage adjustments tailored to your specific situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If your child is experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using the product.

For external anal and genital itching, adults should clean the area with mild soap and warm water, then gently dry it before applying the treatment. If your child is under 12 years old, please seek advice from a doctor before use. Always prioritize your child's safety and well-being by following these guidelines.

Geriatric Use

When considering the use of Equate Hydrocortisone Intensive Healing Formula, it's important to note that there is no specific information available regarding its use in older adults. This means that there are no established guidelines for dosage adjustments, safety concerns, or special precautions tailored for elderly patients.

If you are an older adult or a caregiver, it’s always wise to consult with a healthcare professional before starting any new medication. They can provide personalized advice based on individual health needs and conditions.

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 is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

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 may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20° to 25°C (68° to 77°F). This temperature range helps maintain the product's effectiveness. Additionally, be sure to check the carton or tube crimp for important information such as the lot number and expiration date, which are essential for tracking the product's safety and quality.

When handling the product, always do so with clean hands and in a safe environment to avoid contamination. Following these guidelines will help you use the product safely and effectively.

Additional Information

The medication is administered topically, meaning it is applied directly to the skin. There are no additional details available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences. If you have any specific questions or concerns about using this medication, it's best to consult your healthcare provider for personalized advice.

FAQ

What is Hydrocortisone Cream 1% used for?

Hydrocortisone Cream 1% is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone Cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any contraindications for using this cream?

Do not use in the genital area if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should I do if my condition worsens?

Stop using the cream and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is it safe to use Hydrocortisone Cream during pregnancy?

The safety of hydrocortisone during pregnancy has not been established, so consult a doctor before use if you are pregnant or planning to become pregnant.

What are the side effects of Hydrocortisone Cream?

For external use only, avoid contact with eyes, and do not use more than directed. If swallowed, seek medical help immediately.

Can I use this cream for external anal and genital itching?

Yes, for external anal and genital itching, clean the area with mild soap and warm water, dry gently, and apply the cream not more than 3 to 4 times daily. Consult a doctor for children under 12.

What should I do if I accidentally swallow the cream?

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

Packaging Info

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

Packaging configurations for Equate Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

NDC 49035-973-27. This product is equate™ Hydrocortisone Cream 1% Intensive Healing Formula, designed for maximum strength antipruritic (anti-itch) relief. It contains the active ingredient hydrocortisone, comparable to Cortizone•10® Intensive Healing Formula. The formulation is enriched with antioxidants and chamomile, and includes healing moisturizers fortified with vitamins A, D, and E. The product is presented in a cream dosage form, with a net weight of 2 ounces (60 grams).

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, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides temporary relief for external anal and genital itching.

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 the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended dosage for adults and children aged 2 years and older is to apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth. The medication should then be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, consultation with a physician is also recommended before application.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the genital area is contraindicated in patients with vaginal discharge; medical consultation is advised.

  • The product should not be used for the treatment of diaper rash; consultation with a healthcare professional is recommended.

Additionally, if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear and recur within a few days, discontinue use and consult a doctor. Rectal bleeding is also a contraindication for use.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area in the presence of vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. It is also not indicated for the treatment of diaper rash, and patients should be directed to seek medical advice before use in this context.

Healthcare professionals should instruct patients to avoid contact with the eyes while using this product. It is imperative that patients adhere strictly to the recommended dosage; they should not exceed the directed amount unless specifically instructed by a physician.

Direct application into the rectum using fingers, mechanical devices, or applicators is contraindicated. Patients must be advised to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

In the event of rectal bleeding, patients should stop use immediately and seek medical attention. It is essential to keep this product out of reach of children. In cases of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, the product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is important not to exceed the directed use unless specifically instructed by a doctor. The product should not be administered directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, patients should not begin the use of any other hydrocortisone product without consulting a doctor. Immediate medical attention should be sought if rectal bleeding occurs.

In the event of accidental ingestion, patients should seek medical help or contact a Poison Control Center without delay.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Equate Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may use the medication for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. For children under 12 years of age, it is recommended to seek a doctor's advice before using the product.

Geriatric Use

Elderly patients may not have specific information regarding the use of Equate Hydrocortisone Intensive Healing Formula, as the drug insert does not provide details on dosage adjustments, safety concerns, or special precautions for this population.

Healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the absence of targeted data. Monitoring for potential adverse effects and therapeutic efficacy is advisable, given the variability in drug response among elderly individuals.

Pregnancy

The safety of hydrocortisone during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. There may be potential risks to the fetus associated with the use of hydrocortisone; therefore, it is essential that its use is guided by a healthcare professional. Additionally, dosage adjustments may be necessary for pregnant individuals, and specific recommendations should be obtained from a doctor.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and therapeutic efficacy.

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 are advised 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; therefore, a thorough assessment by medical personnel is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are critical 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 these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help or contact a Poison Control Center immediately.

Patients should be informed not to use the product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to emphasize that this product is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Patients should also be advised not to begin the use of any other hydrocortisone product without first consulting a doctor.

If rectal bleeding occurs, patients should stop using the product and seek medical attention. While using this product, patients must be cautioned to avoid contact with their eyes. It is essential to inform patients not to exceed the directed dosage unless specifically instructed to do so by a healthcare professional. Furthermore, patients should be advised against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at a temperature range of 20° to 25°C (68° to 77°F) to maintain its efficacy. Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

The route of administration for the product is topical. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Equate 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 Equate 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.

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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.