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

This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
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 2015
Label revision date
June 10, 2015
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
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 2015
Label revision date
June 10, 2015
Manufacturer
First Aid Only, Inc
Registration number
part348
NDC root
62985-5125
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

This anti-itch cream is designed to provide temporary relief from itching caused by minor skin irritations, inflammation, or rashes. It works by soothing the affected area, helping to alleviate discomfort and promote healing.

While it is effective for first aid purposes, it's important to use this product under the advice and supervision of a doctor for any other uses.

Uses

You can use this product for the temporary relief of itching caused by minor skin irritations, inflammation, or rashes. It's important to remember that if you have other uses in mind for this product, you should consult with your doctor for advice and supervision.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this product, making it a safer option for those concerned about such risks.

Dosage and Administration

You should apply the medication to the affected area no more than 3 to 4 times each day. This helps ensure that you are using it safely and effectively. If you are considering using this medication for a child under the age of 2, it’s important to consult with a doctor first to ensure it’s appropriate for their needs. Always follow these guidelines to get the best results from your treatment.

What to Avoid

It's important to use this product safely. You should never apply it to your eyes, as this can cause irritation or harm. Additionally, avoid using it for treating diaper rash, as it is not intended for that purpose. Following these guidelines will help ensure your safety and the effectiveness of the product.

Side Effects

This product is intended for external use only, so be sure to avoid contact with your eyes and do not use it for treating diaper rash. If your condition worsens, lasts more than seven days, or clears up only to return within a few days, you should stop using the product and consult a doctor. Additionally, if you are using other hydrocortisone products, it's important to seek medical advice.

Keep this product out of reach of children. If it is accidentally ingested, contact a Poison Control Center immediately for assistance.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it for diaper rash. It's important to keep this medication out of reach of children. If a child accidentally ingests it, contact a Poison Control Center immediately.

You should stop using the product and consult your doctor if your condition worsens, lasts more than 7 days, or if it clears up and then comes back within a few days. Additionally, avoid using this product alongside other hydrocortisone products without first speaking to your healthcare provider.

Overdose

If you suspect an overdose has occurred, it’s important to act quickly. Contact a Poison Control Center immediately for guidance. They can provide you with the necessary steps to take based on the situation.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice any concerning changes in your health or behavior, don’t hesitate to seek immediate medical help. Your safety is the top priority, so getting professional assistance as soon as possible is crucial.

Pregnancy Use

When considering the use of hydrocortisone cream during pregnancy, it's important to note that the provided information does not include specific statements about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there is no clear guidance on how this medication may affect you or your developing baby.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication, including hydrocortisone cream. They can help you weigh the potential benefits and risks based on your individual situation.

Lactation Use

If you are breastfeeding, you can use hydrocortisone cream without specific warnings or recommendations against it. The information available does not indicate any particular concerns or precautions for nursing mothers regarding the use of this cream.

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

Pediatric Use

If you have a child under the age of 2, it's important to consult with a doctor before using this medication. This ensures that the treatment is safe and appropriate for your little one. Always prioritize professional guidance when it comes to the health of young children.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

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, especially if you have concerns about your kidney health. They can provide guidance based on your individual situation.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the medication may need to be adjusted or monitored based on your liver function.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for you, especially if you have a history of liver issues. Your doctor can help determine the best approach based on your individual health needs.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no known drug interactions or laboratory test interactions associated with them. This ensures that your treatment plan is safe and effective for your individual health needs.

Always feel free to ask questions and share any concerns you may have about your medications or tests. Your healthcare provider is there to help you understand how to manage your health safely.

Storage and Handling

To ensure the best performance of your product, store it at room temperature and keep it away from direct light. It's important not to freeze the product, as this can affect its effectiveness. Once you open the product, be sure to discard it after use to maintain safety and quality.

By following these simple storage and handling guidelines, you can help ensure that the product remains safe and effective for your needs.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is the primary use of this anti-itch cream?

This anti-itch cream is used for temporary relief of itching associated with minor skin irritations, inflammation, or rashes.

How often can I apply the cream?

You can apply the cream to the affected area not more than 3 to 4 times daily.

Are there any specific warnings for this cream?

Yes, it is for external use only, and you should not use it in the eyes or for the treatment of diaper rash.

What should I do if my condition worsens?

If your condition worsens or lasts more than 7 days, or if it clears up and occurs again within a few days, you should stop use and ask a doctor.

Is this cream safe for children?

For children under 2 years old, you should ask a doctor before use.

What should I do if the cream is ingested?

If ingested, contact a Poison Control Center right away.

Are there any contraindications for this cream?

No specific contraindications are mentioned for this cream.

How should I store this cream?

Store the cream at room temperature, protect it from light, and do not freeze. Discard it after opening.

Can I use this cream while pregnant or nursing?

There are no specific warnings or recommendations regarding the use of this cream during pregnancy or while nursing.

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

This anti-itch cream is formulated for first aid use, providing relief from itching. The product is packaged in a 0.9g (1/32 OZ) tube. It is manufactured by Acme United Corporation, located in Fairfield, CT 06824. For further information, the company can be contacted at 1.800.835.2263 or through their website at www.FirstAidOnly.com. The product is identified by the code 810002-revA and is protected under copyright © 2015 Acme United Corporation.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations, inflammation, or rashes.

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

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

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. For children under the age of 2, it is advised to consult a physician prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the eyes due to the potential for irritation or adverse effects. Additionally, it is contraindicated for the treatment of diaper rash, as it may not be effective or appropriate for this condition.

Warnings and Precautions

For external use only. This product is contraindicated for application in the eyes and should not be used for the treatment of diaper rash.

Healthcare professionals should advise patients to discontinue use and consult a physician if the condition worsens, persists for more than 7 days, or resolves and then recurs within a few days. Additionally, caution is warranted if the patient is concurrently using other hydrocortisone products, as this may lead to increased risk of adverse effects.

It is imperative to keep this product out of reach of children. In the event of ingestion, immediate contact with a Poison Control Center is recommended to ensure appropriate management.

Side Effects

Patients should be aware that the product is for external use only. It is contraindicated for use in the eyes and should not be used for the treatment of diaper rash.

In the event that the condition worsens or persists for more than 7 days, or if the condition clears up and then recurs within a few days, patients are advised to stop use and consult a doctor. Additionally, caution is advised against the concurrent use of other hydrocortisone products.

It is important to keep this product out of reach of children. Ingestion of the product necessitates immediate contact with a Poison Control Center.

Drug Interactions

No specific drug interactions have been identified for this medication. 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 Hydrocortisone. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Hydrocortisone.
Details

Pediatric Use

Pediatric patients under the age of 2 years should consult a healthcare professional before use. It is important to assess the appropriateness of treatment in this age group, as specific dosing and safety considerations may apply.

Geriatric Use

There is no specific information regarding the use of this medication 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in 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, the available data does not provide clear guidance on the potential risks or fetal impacts associated with its use in pregnant patients. Healthcare professionals should consider the lack of information and weigh the benefits against any potential risks when prescribing this medication to women of childbearing potential. It is advisable to monitor pregnant patients closely and to discuss any concerns regarding the use of hydrocortisone cream during pregnancy with them.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation or breastfeeding mentioned in the provided text.

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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

Overdosage

In the event of an overdosage, immediate action is crucial. Healthcare professionals are advised to contact a Poison Control Center without delay if an overdose is suspected.

Prompt communication with a Poison Control Center can facilitate the assessment of the situation and guide the appropriate management of the patient. It is essential to provide detailed information regarding the substance involved, the amount ingested, and the time of ingestion to ensure effective intervention.

Monitoring for potential symptoms of overdosage is also critical, although specific symptoms are not detailed in the provided information. Healthcare professionals should remain vigilant and prepared to manage any adverse effects that may arise as a result of the overdose.

In summary, swift action and communication with a Poison Control Center are imperative in managing cases of overdosage effectively.

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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients that in the event of ingestion, it is crucial to contact a Poison Control Center immediately. This action is essential to ensure the safety and well-being of the patient. Providers should emphasize the importance of prompt communication with medical professionals in such situations to facilitate appropriate care and intervention.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at room temperature, ensuring that it is protected from light exposure. Freezing the product is not permitted, as it may compromise its integrity. Additionally, once opened, the product must be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered topically, with application to the affected area recommended no more than 3 to 4 times daily. 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 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.