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Family Wellness

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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 2017
Label revision date
October 27, 2023
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 2017
Label revision date
October 27, 2023
Manufacturer
FRONT PHARMACEUTICAL PLC
Registration number
M017
NDC root
69571-009
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.

In addition to addressing general skin irritations, this drug is effective for relieving external and genital itching. However, for any other uses, it is important to consult with a doctor for proper guidance and supervision.

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 such as eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, as well as irritation caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

In addition to these uses, it can relieve external and genital itching. However, 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, skin irritation, inflammation, or rashes, you can apply the medication to the affected area. For adults and children aged 2 years and older, it's recommended to use it no more than 3 to 4 times a day. However, if your child is under 2 years old, it's best to consult a doctor before use.

For external and genital itching in adults, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. After cleaning, pat the area dry with toilet tissue or a soft cloth before applying the medication. Again, you should apply it no more than 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to keep this medication out of reach of children. If a child accidentally swallows it, seek medical help or contact a Poison Control Center immediately. There are no specific contraindications, risks of abuse or misuse, or concerns about dependence associated with this medication, but always use it responsibly and as directed.

Side Effects

When using this product, it's important to be aware of some potential side effects and warnings. You should only use it externally and avoid applying it in the genital area if you have vaginal discharge or for treating diaper rash—consult a doctor in these cases. Be careful to keep the product away from 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 improve and then return within a few days, stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on internal areas like the genital region if you have vaginal discharge or for treating diaper rash—consult your doctor in these cases. While using this product, be careful to keep it away from your eyes, and do not exceed the recommended dosage unless directed by your doctor. Additionally, do not insert it directly into the rectum using your fingers or any device.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. It's also important to seek medical advice if you experience rectal bleeding. In case of accidental swallowing, get emergency medical help or contact a Poison Control Center immediately.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contacting your local emergency services or going to the nearest hospital is crucial. Always keep the medication packaging with you, as it can help healthcare professionals understand what you've taken. Remember, it's better to be safe and get checked out if you have any concerns about an overdose.

Pregnancy Use

When considering the use of FAMILY WELLNESS hydrocortisone 1% cream during pregnancy, it's important to note that the drug insert does not provide specific information about its safety, dosage adjustments, or any special precautions for pregnant individuals. This means that there is no clear guidance on how this cream 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 over-the-counter creams. They can help you weigh the potential benefits and risks based on your individual health needs.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Therefore, exercising caution while using this product during breastfeeding is highly recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

If your child is experiencing itching, 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 and genital itching, please consult a doctor if your child is under 12 years of age. Always prioritize your child's safety and seek professional advice when needed.

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. If you or a loved one is an older adult, it’s always a good idea to discuss any medications with a healthcare provider. They can help ensure that the treatment is safe and appropriate, considering any unique health needs or conditions.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. Always keep them informed about any other medications or health issues to help manage your care effectively.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations related to renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may want to conduct regular liver function tests (which check how well your liver is working) to ensure your safety while using any medication.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safety and compliance with local regulations.

Additional Information

You can use this medication topically, applying it to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If the patient is under 2 years old or under 12 years old, it's important to consult a doctor before use. This medication is intended for external use, including for genital itching. Always follow your healthcare provider's guidance for safe and effective use.

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 drug for itching or skin irritation?

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.

Are there any warnings I should be aware of?

Yes, avoid contact with eyes, do not use more than directed, and do not apply directly into the rectum. Consult a doctor if symptoms worsen or persist.

Can I use this drug if I am pregnant or breastfeeding?

There are no specific safety concerns mentioned for use during pregnancy, but nursing mothers should consult a doctor before use due to potential excretion in breast milk.

What should I do if I accidentally swallow this drug?

Get emergency medical help or contact a Poison Control Center right away if swallowed.

Is there any specific storage requirement for this drug?

Store the drug at room temperature between 68° - 77° F (20° - 25° C).

Packaging Info

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

Packaging configurations for Family Wellness.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

The provided information does not specify the chemical name, physical characteristics, or inactive ingredients of the drug. Therefore, a detailed description cannot be formulated based on the available data. Further information is required to create a comprehensive description.

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, poison oak, poison sumac, insect bites, and reactions to detergents, jewelry, cosmetics, and soaps. Additionally, it provides temporary relief for external 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, skin irritation, inflammation, and rashes, the following dosage and administration guidelines are recommended:

Adults and children aged 2 years and older should 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 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, gently dry the area 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 is contraindicated in children due to the risk of accidental ingestion. In the event of swallowing, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if vaginal discharge is present; consultation with a healthcare professional is advised. It is also not indicated for the treatment of diaper rash, and a doctor should be consulted in such cases.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed by a healthcare provider. Direct application into the rectum using fingers, mechanical devices, or applicators is contraindicated.

Patients should 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 not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional. Additionally, if rectal bleeding occurs, medical attention should be sought immediately.

In the event of accidental ingestion, emergency medical assistance should be obtained, or the local Poison Control Center should be contacted without delay.

Side Effects

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

While using this product, patients must avoid contact with the eyes and should not exceed the recommended dosage unless directed by a healthcare professional. It is also important to 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. Furthermore, if rectal bleeding occurs, patients should stop using the product and seek medical advice.

Drug Interactions

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

Packaging & NDC

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

Packaging configurations for Family Wellness.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching, skin irritation, inflammation, and rashes up to 3 to 4 times daily. For children under 2 years of age, it is advised to consult a doctor prior to use.

In cases of external and genital itching, it is recommended that children under 12 years of age also seek medical advice before application.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There are no specific statements regarding the use of FAMILY WELLNESS hydrocortisone 1% cream during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. As such, healthcare professionals should consider the lack of data when advising women of childbearing potential about the use of this medication during pregnancy. It is recommended that the potential benefits be weighed against any unknown risks to fetal outcomes.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients 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 the use of this medication. Consequently, there are no established 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 prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or symptoms that may arise from excessive dosing.

In the event of suspected overdosage, immediate medical attention should be sought. Healthcare providers should implement supportive measures as necessary, which may include symptomatic treatment and monitoring of vital signs.

Due to the lack of detailed overdosage information, it is recommended that healthcare professionals refer to established clinical guidelines and protocols for managing overdose situations relevant to the specific medication in question. Additionally, contacting a poison control center may provide further guidance on appropriate management strategies.

Continued vigilance and patient assessment are crucial in mitigating potential risks associated with 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is crucial to inform patients that if the medication is swallowed, they should seek medical help or contact a Poison Control Center immediately. This guidance is essential to ensure the safety and well-being of patients and to mitigate any potential risks associated with accidental ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product at room temperature, maintaining a range of 68° to 77° F (20° to 25° C). Proper storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with the recommended frequency for adults and children aged 2 years and older being 3 to 4 applications to the affected area daily. For children under 2 years of age, consultation with a doctor is advised before use. Additionally, adults experiencing external and genital itching should also apply the medication to the affected area no more than 3 to 4 times daily, while caregivers of children under 12 years should seek medical advice prior to administration.

No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experiences.

Drug Information (PDF)

This file contains official product information for Family Wellness, 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, 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

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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.