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Family Care Anti-Itch

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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 2022
Label revision date
October 20, 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 2022
Label revision date
October 20, 2025
Manufacturer
United Exchange Corp.
Registration number
M017
NDC root
65923-494
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 medication is used to help relieve itching caused by skin irritation, inflammation, and rashes. It is suitable for adults and children aged 2 years and older, and it can be applied to the affected area up to 3 to 4 times a day. For children under 2 years of age, it's important to consult a doctor before use.

When using this medication for external anal and genital itching, it's recommended to clean the area with mild soap and warm water, then gently dry it before applying the medication. This approach helps ensure effective relief from discomfort.

Uses

If you're dealing with itching caused by skin irritation, inflammation, or rashes, this medication can help relieve your discomfort. You can also use it for external anal and genital itching. For adults, it's recommended to apply the product to the affected area no more than 3 to 4 times a day.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. Always follow the application guidelines to ensure safe and effective use.

Dosage and Administration

It seems that there is no specific dosage or administration information available for the medication you are inquiring about. This means that details on how to take or apply the medication, including the amount and frequency, are not provided.

If you have any questions or need guidance on how to use this medication, it’s best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized advice based on your health needs.

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 more than the directed amount unless your doctor advises otherwise. Never apply the product directly into the rectum using your fingers or any device.

While using this product, be careful to keep it away from your eyes. If your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult your doctor. Remember, do not start any other hydrocortisone product without first speaking to your healthcare provider.

Side Effects

This medication is intended for external use only. It's important to monitor your condition while using it. If your symptoms worsen, persist for more than 7 days, or improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately. Please do not start any other hydrocortisone product without first discussing it with your healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that may be sensitive or not intended for topical treatment. Keep it out of reach of children, and if it is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

You should stop using this product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, if you experience any rectal bleeding, it is important to stop use and reach out to your healthcare provider right away.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it’s always important to be aware of the signs of an overdose, which can include unusual symptoms or worsening of your condition. If you suspect that you or someone else may have taken too much of the medication, it’s crucial to seek immediate medical help.

In case of an overdose, you should contact your healthcare provider or local emergency services right away. They can provide guidance on what steps to take next. Always keep medications out of reach and follow the prescribed dosage to minimize the risk of an overdose.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

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 in adults, it's recommended to clean the area with mild soap and warm water, then gently dry it before applying the treatment. This can also be done up to 3 to 4 times daily. Always ensure that you follow these guidelines to keep your child safe and comfortable.

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, it’s important to consult with a healthcare provider for personalized advice. 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 kidney function might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for your specific condition. They can help determine the best approach 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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20-25°C (68-77°F). This temperature range helps maintain its effectiveness and safety.

When handling the product, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided with the product for safe use and disposal. Keeping these guidelines in mind will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. If the patient is under 2 years old, consult a doctor before use. For external anal and genital itching, adults can also apply it to the affected area up to 3 to 4 times daily.

If you are pregnant or breastfeeding, it's important to ask a health professional before using this medication. Always keep it out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is this drug used for?

This drug is used for treating itching caused by skin irritation, inflammation, and rashes, as well as for external anal and genital itching.

How should I apply this drug?

For adults and children 2 years and older, apply to the affected area no more than 3 to 4 times daily. For children under 2 years, consult a doctor.

What should I do before applying the drug for external anal and genital itching?

Clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before applying the drug.

Are there any contraindications for using this drug?

Do not use in the genital area if you have a vaginal discharge or for the treatment of diaper rash. Consult a doctor for guidance.

What should I do if my condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is this drug safe for use during pregnancy or breastfeeding?

If you are pregnant or breastfeeding, consult a health professional before using this drug.

What precautions should I take when using this drug?

This drug is for external use only. Keep it out of reach of children, and if swallowed, seek medical help immediately.

What should I avoid while using this drug?

Avoid contact with eyes and do not apply directly into the rectum using fingers or any device.

Packaging Info

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

Packaging configurations for Family Care Anti-Itch.
Details

Drug Information (PDF)

This file contains official product information for Family Care Anti-Itch, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of itching associated with skin irritation, inflammation, and rashes. It is specifically indicated for external anal and genital itching in adults. The recommended application is to the affected area, not to exceed 3 to 4 times daily.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

No dosage and administration information is available for this product. Healthcare professionals are advised to consult the prescribing information or relevant clinical guidelines for specific dosing recommendations and administration techniques.

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.

  • Administration should not exceed the directed dosage unless specifically instructed by a physician.

  • Direct insertion into the rectum using fingers, mechanical devices, or applicators is prohibited.

Additionally, contact with the eyes must be avoided. If the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and recur within a few days, discontinue use and consult a doctor. Rectal bleeding also necessitates immediate medical consultation.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a physician if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or symptoms resolve and then recur within a few days. Patients should refrain from using any other hydrocortisone products without prior consultation with a healthcare provider. Additionally, if rectal bleeding is observed, patients must stop using the product and seek medical advice promptly.

Side Effects

Patients should be aware that the product is intended for external use only.

In the event of adverse reactions, it is advised to discontinue use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should refrain from using any other hydrocortisone products without prior consultation with a doctor.

Patients should also seek medical attention if rectal bleeding occurs, as this may indicate a more serious condition requiring immediate evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Packaging configurations for Family Care Anti-Itch.
Details

Pediatric Use

For the treatment of itching associated with skin irritation, inflammation, and rashes, the recommended application for pediatric patients aged 2 years and older is to apply the product 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, adults are instructed to clean the affected area with mild soap and warm water, rinsing thoroughly. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product. The same frequency of application, not more than 3 to 4 times daily, applies to this indication as well.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

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 absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, altered mental status, or any unusual physiological responses.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on managing overdose cases.

In summary, while no specific overdosage information is provided, healthcare professionals should exercise caution, remain alert to potential overdose symptoms, and implement appropriate management strategies as needed.

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 the medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for further assistance. It is important for patients to understand the urgency of the situation and the appropriate steps to take if an accidental ingestion occurs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, within the range of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

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, consultation with a doctor is advised. In cases of external anal and genital itching, adults should also apply to the affected area no more than 3 to 4 times daily.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Family Care Anti-Itch, 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 Family Care Anti-Itch, 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.