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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 2013
Label revision date
October 24, 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 2013
Label revision date
October 24, 2023
Manufacturer
Zhejiang Jingwei Pharmaceutical Co. , Ltd.
Registration number
M017
NDC root
55621-008
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 provides temporary relief from itching caused by various minor skin irritations, inflammation, and rashes. You may find it helpful for conditions such as eczema, insect bites, and reactions to poison ivy, poison oak, or poison sumac. It can also alleviate itching related to soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, and external genital, feminine, and anal itching.

While this product is effective for these uses, it's important to consult with a doctor for any other applications. Always ensure you are using it as directed for the best results.

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, insect bites, and reactions to plants like poison ivy, poison oak, and poison sumac. It can also help with irritation from soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. Additionally, it is effective for external genital, feminine, and anal itching.

If you have other uses in mind, it's important to consult with your doctor for advice and supervision.

Dosage and Administration

If you're dealing with itching from skin irritation, inflammation, or rashes, you can apply the medication to the affected area up to 3 or 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 use.

For external itching around the anal and genital areas, adults should first clean the area with mild soap and warm water, then rinse and dry it thoroughly. After that, you can apply the medication to the affected area, again up to 3 or 4 times daily. If the person needing treatment is a child under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to be aware of certain guidelines when using this medication. You should stop using it and consult your doctor if your symptoms persist for more than 7 days, worsen, or if they improve and then return within a few days. Additionally, if you experience any rectal bleeding, you must seek medical advice immediately.

While there are no specific contraindications or concerns regarding controlled substances, abuse, or dependence associated with this medication, it's always best to use it responsibly and follow your healthcare provider's recommendations. Your health and safety are paramount, so don't hesitate to reach out to your doctor with any questions or concerns.

Side Effects

When using this product, it's important to be aware of potential side effects. You should stop using it and consult a doctor if your symptoms last longer than 7 days, worsen, or if they improve and then return within a few days. Additionally, if you experience rectal bleeding, seek medical advice immediately.

This product is for external use only and should not be applied to the genital area if you have a vaginal discharge or used for diaper rash without consulting a doctor. Always avoid contact with your eyes and do not exceed the recommended dosage unless directed by a healthcare professional. Remember, do not insert this product into the rectum using fingers or any other device.

Warnings and Precautions

This product is for external use only, so please avoid using it on your genital area if you have a 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 your doctor advises you to. It's important not to insert this product into the rectum using fingers or any devices.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. You should stop using the product and call your doctor if your symptoms last longer than 7 days, worsen, clear up and then return within a few days, or if you experience rectal bleeding.

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 concerned about a possible overdose, 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 provide important information to healthcare professionals. Remember, it's better to be safe and get checked if you have any doubts about your health.

Pregnancy Use

There is currently no specific information available about the use of hydrocortisone cream during pregnancy, including safety concerns, dosage adjustments, or any special precautions you should take. If you are pregnant or planning to become pregnant, it is important to consult your healthcare provider before using this medication. They can help you weigh the potential benefits and risks based on your individual situation.

Lactation Use

If you are breastfeeding or planning to breastfeed, 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. Additionally, the safety of this product during lactation has not been established, so discussing your options with a healthcare professional is crucial to ensure the well-being of both you and your baby.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children under 12 years old who are experiencing itching in the anal or genital areas, you should also seek advice from a healthcare professional.

For children aged 2 years and older, you can apply the medication to the affected area, but be sure to limit the application to no more than 3 or 4 times a day. Always follow your doctor's guidance to ensure the safety and effectiveness of the treatment for your child.

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 plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

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 ensure that any medication you take is safe and appropriate for your liver health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

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 keep your healthcare team informed about all the medications and supplements you use, as well as any lab tests you may undergo. This way, they can provide the best care tailored to you.

Storage and Handling

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

When handling the product, be sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use and disposal to ensure safety and effectiveness.

Additional Information

You should apply this medication topically to the affected area no more than 3 or 4 times daily if you are an adult or a child aged 2 years and older. For external anal and genital itching, adults can also use it in the same manner. Remember, this product is for external use only, so keep it out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Avoid using this product in the genital area if you have a vaginal discharge, and consult a doctor for diaper rash treatment. Be careful to keep it away from your eyes, and do not use more than directed unless advised by a doctor. Do not insert this product into the rectum using fingers or any device. If your symptoms last longer than 7 days, worsen, return after clearing up, or if you experience rectal bleeding, stop using the product and consult a doctor.

FAQ

What is the primary use of this drug?

This drug provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes.

What conditions can this drug help relieve itching from?

It can relieve itching from conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, seborrheic dermatitis, and external genital, feminine, and anal itching.

How should adults and children over 2 years use this drug?

Adults and children 2 years of age and older should apply it to the affected area no more than 3 or 4 times daily.

What should I do if symptoms last more than 7 days?

You should stop using the product and ask a doctor if symptoms last for more than 7 days.

Are there any contraindications for using this drug?

No specific contraindications are listed, but consult a doctor if you have a vaginal discharge or are treating diaper rash.

What precautions should I take when using this drug?

Avoid contact with eyes, do not use more than directed, and do not apply it into the rectum using fingers or any device.

Is this drug safe to use during pregnancy or while nursing?

Consult a doctor before using this product during pregnancy or if you are nursing, as safety has not been established.

What should I do if I accidentally swallow this drug?

Keep it out of reach of children, and if swallowed, get medical help or contact a Poison Control Center immediately.

Packaging Info

Below are the non-prescription pack sizes of Family Wellness (hydrocortisone). 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 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 but not limited to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, jewelry, detergents, cosmetics, psoriasis, and seborrheic dermatitis. Additionally, it is indicated for external genital, feminine, and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

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

In cases of external anal and genital itching, adults should first cleanse the affected area with mild soap and warm water, ensuring it is rinsed thoroughly. The area should then be dried completely 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 healthcare professional is recommended before use.

Contraindications

There are no specific contraindications listed for this product. However, it is advised to discontinue use and consult a healthcare professional under the following circumstances: if symptoms persist for more than 7 days, if conditions worsen, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised in such cases. It is also not recommended for the treatment of diaper rash without prior medical consultation.

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. Additionally, this product should not be administered rectally using fingers, mechanical devices, or applicators.

General precautions include keeping the product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Patients should discontinue use and consult a healthcare professional if any of the following occur: symptoms persist for more than 7 days, the condition worsens, symptoms resolve and then recur within a few days, or if rectal bleeding is observed.

Side Effects

Patients using this product should be aware of several important warnings and precautions. This product is intended for external use only and should not be applied to the genital area in the presence of vaginal discharge. Additionally, it is not recommended for the treatment of diaper rash without consulting a doctor.

While using this product, patients should avoid contact with the eyes and adhere strictly to the recommended dosage. It is crucial not to exceed the directed use unless advised by a healthcare professional. Furthermore, patients should refrain from inserting this product into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and consult a doctor if symptoms persist for more than 7 days, if the condition worsens, if symptoms resolve and then recur within a few days, or if rectal bleeding occurs. These guidelines are essential to ensure the safe and effective use of the product.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Family Wellness (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness.
Details

Pediatric Use

Pediatric patients under 2 years of age should consult a healthcare professional before use. For children under 12 years of age, particularly for the treatment of external anal and genital itching, it is also advised to seek medical guidance.

For pediatric patients aged 2 years and older, the medication may be applied to the affected area no more than 3 to 4 times daily.

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

There is no specific information regarding the use of hydrocortisone cream during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered if necessary. Women of childbearing potential should be counseled on the absence of established safety data in pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the safety of this product during lactation has not been established. Therefore, healthcare professionals are advised to consider the risks and benefits when recommending this product to nursing 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 relation to the use of this medication. Consequently, there are no 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Consultation with a poison control center or a medical toxicologist may be beneficial for guidance on management strategies tailored to the specific situation.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 question.

Postmarketing Experience

No postmarketing experience details are available for SPL code 90375-7.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and consult a doctor if any of the following occur: symptoms persist for more than 7 days, the condition worsens, symptoms resolve and then reappear within a few days, or if rectal bleeding occurs. It is important for patients to be aware of these signs and to seek medical advice promptly to ensure their safety and well-being.

Storage and Handling

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

Additional Clinical Information

Patients should apply the topical medication to the affected area no more than 3 or 4 times daily. This applies to both adults and children aged 2 years and older. For external anal and genital itching, adults are advised to follow the same frequency of application.

Clinicians should counsel patients to keep the product out of reach of children and to seek medical assistance or contact a Poison Control Center immediately if swallowed. The medication is for external use only and should not be applied in the genital area if there is a vaginal discharge. For diaper rash treatment, consultation with a doctor is recommended. Patients should avoid contact with eyes and not exceed the directed dosage unless advised by a healthcare professional. It is important to refrain from inserting the product into the rectum using fingers or any mechanical device. Patients should discontinue use and consult a doctor if symptoms persist for more than 7 days, worsen, recur after clearing, or if rectal bleeding occurs.

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.