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Family Wellness Maximum Strength Hydrocortisone

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This product has been discontinued

Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
September 19, 2016
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2013
Label revision date
September 19, 2016
Manufacturer
Family Dollar
Registration number
part348
NDC root
55319-074
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 you can apply it to the affected area up to 3 to 4 times a day. If you have a child under 2 years old, it's best to consult a doctor before use.

Uses

You can use this medication to help relieve itching caused by skin irritation, inflammation, and rashes. It is suitable for both adults and children who are 2 years old and older. You should apply it to the affected area no more than 3 to 4 times a day. If your child is under 2 years of age, it's best to consult a doctor before use.

Rest assured, there are no known teratogenic effects (which means it doesn't cause birth defects) associated with this medication, and there are also no reported nonteratogenic effects.

Dosage and Administration

It seems that there are no specific dosage or administration instructions available for this medication. This means that you should consult your healthcare provider for personalized guidance on how to take or use this medication. They will provide you with the necessary information regarding the appropriate dosage, how to administer it, and how often you should do so. Always follow their recommendations to ensure safe and effective use.

What to Avoid

It's important to use this product safely and effectively. You should not apply it in the genital area if you have a vaginal discharge or use it for diaper rash; in these cases, please consult your doctor. Additionally, avoid contact with your eyes and do not exceed the recommended dosage unless directed by a healthcare professional. Never insert this product into the rectum using your fingers or any device.

By following these guidelines, you can help ensure your safety while using this product. If you have any questions or concerns, don't hesitate to reach out to your healthcare provider for advice.

Side Effects

You should only use this product on the skin, as it is meant for external use only. If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, it’s important to stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately. Avoid starting any other hydrocortisone products without first discussing it with your healthcare provider.

Warnings and Precautions

This product is for external use only, so please avoid using it on any internal areas. Keep it out of reach of children, and if it is accidentally swallowed, seek medical help immediately or contact a Poison Control Center.

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 rectal bleeding, it’s important to stop use and reach out to your healthcare provider.

Overdose

If you suspect an overdose, it’s crucial to seek medical help immediately or contact a Poison Control Center. Signs of an overdose can vary, but they often require urgent attention.

Always remember that acting quickly can make a significant difference in your safety and health. If you or someone you know is experiencing symptoms of an overdose, don’t hesitate to reach out for help.

Pregnancy Use

You can use hydrocortisone cream during pregnancy without specific warnings or dosage changes mentioned in the information provided. There are no indications that this cream is contraindicated (not recommended) for pregnant individuals, nor does it state any known risks to the fetus. However, it's always a good idea to consult with your healthcare provider before using any medication during pregnancy to ensure it’s safe for you and your baby.

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 the ingredients may pass into your breast milk, which could affect your nursing infant. Therefore, exercising caution is advised when considering this product while breastfeeding. Always prioritize your health and your baby's well-being by seeking professional guidance.

Pediatric Use

If your child is experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area. For children aged 2 years and older, it is safe to use this treatment up to 3 to 4 times a day. However, if your child is under 2 years old, it’s important to consult with a doctor before using the product. Always ensure 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 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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you may start. Open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally between 20°-25°C (68°-77°F). It's important to keep an eye on the lot number and expiration date, which you can find on the box or the crimp of the tube. This will help you confirm that the product is still safe and effective to use.

When handling the product, always do so with care to maintain its integrity. Make sure to follow any additional safety instructions provided to ensure proper use. If you have any questions about storage or handling, don’t hesitate to reach out for more information.

Additional Information

You should apply this medication topically to the affected area, using it 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, it's important to consult a doctor before use.

FAQ

What is this product used for?

This product is used for itching of skin irritation, inflammation, and rashes.

How should I apply this product?

For adults and children 2 years of age and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years of age, consult a doctor.

Are there any contraindications for using this product?

Do not use this product in the genital area if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

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.

What precautions should I take when using this product?

Avoid contact with the eyes, do not use more than directed unless told to do so by a doctor, and do not put this product into the rectum.

Is this product safe to use during pregnancy?

The insert does not provide specific information regarding the use of this product during pregnancy, so consult a doctor for advice.

Can nursing mothers use this product?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow this product?

If swallowed, get medical help or contact a Poison Control Center right away.

How should I store this product?

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

Packaging Info

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

Packaging configurations for Family Wellness Maximum Strength Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the relief of itching associated with skin irritation, inflammation, and rashes. It is approved for use in adults and children aged 2 years and older, with application to the affected area not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a healthcare professional is advised prior to use.

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

Dosage and Administration

There are currently no specific dosage or administration instructions available for this medication. Additionally, no details regarding the route, method, or frequency of administration have been provided. Healthcare professionals are advised to refer to the prescribing information or clinical guidelines for further guidance on the appropriate use of this medication.

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.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a physician. Furthermore, insertion of the product into the rectum using fingers, mechanical devices, or applicators is prohibited.

Warnings and Precautions

For external use only. This product is intended solely for topical application and should not be ingested.

General precautions must be observed to ensure safety. It is imperative to keep this product out of the reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

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 unless directed by a healthcare provider. Additionally, if rectal bleeding is experienced, patients must stop using the product and seek medical advice promptly.

In cases of ingestion, it is crucial to obtain emergency medical help or contact a Poison Control Center immediately.

Side Effects

For external use only. Patients should be advised to stop 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. Additionally, patients should seek medical advice if rectal bleeding occurs.

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 Maximum Strength Hydrocortisone (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Family Wellness Maximum Strength Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for the relief of itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For infants and children under 2 years of age, it is advised to consult a physician before use.

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 potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Hydrocortisone cream has not been associated with specific warnings, precautions, or dosage modifications for use during pregnancy. The prescribing information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to fetal outcomes. As with any medication, healthcare professionals should weigh the potential benefits against any unknown risks when considering the use of hydrocortisone cream in women of childbearing potential. It is advisable to monitor the patient closely and to use the lowest effective dose for the shortest duration necessary.

Lactation

Lactating mothers should consult a doctor before using this product due to the potential for excretion in breast milk. Caution is advised when using this product while breastfeeding, as the effects on breastfed infants are not fully established.

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 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 available information.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage. Healthcare professionals are advised to assess the situation thoroughly and initiate appropriate management protocols as necessary.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

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 important to emphasize that if the medication is swallowed, patients should seek medical help or contact a Poison Control Center immediately. This guidance is crucial for ensuring the safety and well-being of patients and their families.

Storage and Handling

The product is supplied in various configurations, with specific lot numbers and expiration dates indicated on the packaging or the crimp of the tube. It is essential to store the product at room temperature, maintaining a temperature range of 20° to 25°C (68° to 77°F). Proper handling and storage conditions are crucial to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered topically, with the recommended application frequency for adults and children aged 2 years and older being no more than 3 to 4 times daily to the affected area. For children under 2 years of age, it is advised to consult a doctor prior to use. There is no additional information available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Family Wellness Maximum Strength Hydrocortisone, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.