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Family Wellness Max Strength 1 Hydrocortisone Cream

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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 2024
Label revision date
February 25, 2025
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 2024
Label revision date
February 25, 2025
Manufacturer
Family Dollar Stores, Inc
Registration number
M017
NDC root
55319-982
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 designed to temporarily relieve itching caused by minor skin irritations, inflammation, and rashes. You may find it helpful for conditions such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It can also provide relief from itching due to insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it is used to temporarily alleviate external anal and genital itching.

For any other uses, it's important to consult with a doctor for guidance and supervision. This ensures that you are using the medication safely and effectively for your specific needs.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations, including conditions like eczema and psoriasis, as well as reactions to poison ivy, oak, and sumac. It can also help soothe itching from insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to these uses, it can relieve external itching in the anal and genital areas. If you have other concerns or conditions, it's best to consult with your doctor for guidance on how to use this product safely.

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 if you are an adult or a child aged 2 years and older. However, if your child is under 2 years old, it's best to consult a doctor before using it.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, rinsing thoroughly. After cleaning, gently dry the area by patting it 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 needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely to avoid potential issues. 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, do not exceed the recommended dosage unless directed by your healthcare provider, and avoid inserting the product directly into the rectum using fingers or any devices.

While using this product, be careful to keep it away from your eyes to prevent irritation. Always prioritize your health and consult a healthcare professional if you have any concerns or questions.

Side Effects

You should be aware that this product is for external use only. Avoid using it in the genital area if you have a vaginal discharge or for treating diaper rash; in these cases, consult a doctor. While using the product, take care to avoid contact with your eyes and do not exceed the recommended dosage unless directed by a healthcare professional.

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

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. If you have a vaginal discharge, do not use it in the genital area and consult your doctor. Additionally, it is not intended for treating diaper rash; please speak with a healthcare professional for appropriate options.

You should stop using this product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Also, seek medical advice if you experience rectal bleeding. Remember to keep this product out of reach of children, and if it is swallowed, get medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed a medication and you suspect an overdose, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Center. They can provide you with the necessary guidance and support.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, it’s always better to be safe and get professional advice in these situations.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that the safety of hydrocortisone cream during pregnancy has not been established. Before using this medication, you should consult your doctor to discuss your specific situation. They can help determine if it's appropriate for you and may suggest dosage adjustments based on your needs.

Always use hydrocortisone cream only if it is clearly necessary, and ensure that the potential benefits outweigh any risks to your baby. Your healthcare provider will guide you on the best course of action to take during this time.

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. This means that, based on current knowledge, you can use this product without concern for its effects on your milk production or your baby.

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. For children under 12 years old, you should also seek advice from a doctor before use. Always prioritize your child's safety and well-being by following these guidelines.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. As you age, your body may process medications differently, and factors like kidney function (renal impairment) and changes in cognition can affect how well a drug works or how safe it is for you.

If you or a loved one is considering this medication, it’s wise to discuss it with a healthcare provider. They can help determine the best approach, taking into account any unique health needs or concerns that may arise with age. 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 drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 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 the medication is generally considered safe to use with other drugs and tests. However, every individual is different, and your healthcare provider can help ensure that your treatment plan is safe and effective for you.

Always remember that discussing your full list of medications and any lab tests with your healthcare provider is crucial. This way, you can avoid any potential issues and receive the best care tailored to your needs.

Storage and Handling

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

When handling the product, be sure to check the packaging carefully. It is tamper-evident, meaning you should not use it if the foil seal is broken or missing, as this could indicate that the product has been compromised. Following these guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily. This guidance applies to both adults and children aged 2 years and older. If you are treating external anal and genital itching, adults should also follow the same application frequency. Always ensure you are using the medication as directed for the best results.

FAQ

What conditions can this drug help relieve?

This drug temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, poison ivy, insect bites, and more.

How should I use this product for skin irritation?

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.

What should I do if I experience rectal bleeding?

Stop use and ask a doctor if rectal bleeding occurs.

Can I use this product if I have a vaginal discharge?

No, do not use this product in the genital area if you have a vaginal discharge; consult a doctor.

Is this product safe to use during pregnancy?

The safety of this product during pregnancy has not been established, so consult a doctor before use.

What precautions should I take when using this product?

Avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum.

What should I do if my condition worsens or does not improve?

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

How should I store this product?

Store at room temperature between 68°F to 77°F (20°C to 25°C) and do not use if the foil seal is broken or missing.

Packaging Info

Below are the non-prescription pack sizes of Family Wellness Max Strength 1 Hydrocortisone Cream (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Max Strength 1 Hydrocortisone Cream.
Details

Drug Information (PDF)

This file contains official product information for Family Wellness Max Strength 1 Hydrocortisone Cream, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

The product is identified by the SPL code 34089-3. No specific description details are provided in the text.

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 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

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. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. The medication should 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 prior to use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, direct application into the rectum using fingers, mechanical devices, or applicators is prohibited.

Care should be taken to avoid contact with the eyes during use.

Warnings and Precautions

For external use only. This product is contraindicated for application in the genital area if there is a vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a healthcare provider.

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 resolve and then recur within a few days. It is important to refrain from using any other hydrocortisone products unless directed by a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

This product must be kept out of reach of children. In the event of accidental ingestion, it is crucial to obtain medical assistance or contact a Poison Control Center 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. Furthermore, patients should refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is also crucial to seek medical advice if rectal bleeding occurs.

To ensure safety, this product should be kept 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.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Family Wellness Max Strength 1 Hydrocortisone Cream (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Max Strength 1 Hydrocortisone Cream.
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, consultation with a healthcare professional 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 the area before application. This product should also be applied no more than 3 to 4 times daily. For children under 12 years of age, it is recommended to seek advice from a healthcare provider before use.

Geriatric Use

There is no specific information available 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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use. Dosage adjustments may be necessary, and it is essential to seek guidance from a healthcare professional regarding appropriate dosing.

Hydrocortisone cream should be used only if clearly needed, and the potential benefits must justify any potential risks to the fetus. Careful consideration of the risks versus benefits is advised in this population.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and 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 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; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action and management strategies.

Healthcare providers should ensure that patients are aware of the importance of timely reporting of any suspected overdosage to facilitate effective treatment and minimize risks.

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 understanding of the potential toxicological profile in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that the product should not be used in the genital area if they have a vaginal discharge and that they should consult a doctor in such cases. Additionally, patients should be cautioned against using the product for the treatment of diaper rash and should seek medical advice if they are considering its use for this purpose.

Patients should be instructed 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. They should also be advised not to begin the use of any other hydrocortisone product without first consulting a healthcare professional. Furthermore, patients should be made aware that they need to stop using the product and seek medical attention if rectal bleeding occurs.

When using the product, patients should be reminded to avoid contact with their eyes. It is essential to communicate that the product should not be used in greater amounts than directed unless specifically instructed to do so by a doctor. Lastly, patients should be cautioned against inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Storage and Handling

The product is supplied in a tamper-evident container. It is essential to inspect the foil seal prior to use; the product should not be utilized if the seal is broken or missing.

For optimal storage, the product must be kept at room temperature, specifically within the range of 68°F to 77°F (20°C to 25°C). Proper adherence to these storage conditions is crucial to maintain the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for both adults and children aged 2 years and older. For external anal and genital itching, adults should also apply the medication to the affected area up to 3 to 4 times daily.

No additional information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Family Wellness Max Strength 1 Hydrocortisone Cream, 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 Wellness Max Strength 1 Hydrocortisone Cream, 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.