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Western Family

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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 1995
Label revision date
March 14, 2013
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 1995
Label revision date
March 14, 2013
Manufacturer
Western Family Foods Inc
Registration number
part348
NDC root
55312-013
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

Hydrocortisone is a 1% anti-itch cream designed to provide temporary relief from itching caused by minor skin irritations and rashes. It can be particularly helpful for conditions such as eczema, insect bites, poison ivy, poison oak, poison sumac, and reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

This cream works by reducing inflammation and soothing the affected area, making it easier for you to manage discomfort. While it is effective for many common skin issues, it's important to use it as directed and consult a doctor for any other uses.

Uses

This product is designed to provide temporary relief from itching caused by various minor skin irritations and rashes. You can use it for conditions such as eczema, insect bites, and reactions to plants like poison ivy, poison oak, or poison sumac. It can also help soothe itching from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and even external genital and anal itching.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

Dosage and Administration

If you are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. For those dealing with external anal itching, it’s important to first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the product.

If your child is under 2 years old, do not use this medication and consult a doctor instead. Additionally, if your child is under 12 years of age, it’s best to check with a doctor before use to ensure safety and proper guidance.

What to Avoid

You should avoid using this product in your eyes, as it is not safe for that purpose. Additionally, do not insert this product into the rectum using your fingers or any mechanical device or applicator. Following these guidelines is important to ensure your safety and the effectiveness of the product.

Side Effects

When using this product, it's important to be aware of certain side effects and precautions. You should not use it in your eyes or insert it into the rectum using fingers or any device. If you have a vaginal discharge, rectal bleeding, or diaper rash, consult a doctor before using this product.

While using it, do not exceed the recommended dosage. If your condition worsens, lasts more than 7 days, or clears up only to return within a few days, stop using the product and consult a doctor. Additionally, keep this product out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is intended for external use only, so please avoid contact with your eyes and do not insert it into the rectum using fingers or any devices. Before using this product, it's important to consult your doctor if you have any vaginal discharge, rectal bleeding, or diaper rash.

While using this product, be sure to follow the recommended dosage. If your condition worsens, lasts longer than 7 days, or clears up only to return within a few days, stop using it and contact your doctor. Additionally, keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to avoid using this medication. The potential risks during pregnancy are significant, and it is crucial to consult your doctor before considering any use. Your healthcare provider can help you understand the safest options for your health and the health of your baby.

Lactation Use

When it comes to breastfeeding, it's important to be aware that there are no specific guidelines or statements regarding nursing mothers or lactation (the process of producing milk). This means that if you are breastfeeding, you should consult with your healthcare provider for personalized advice and to discuss any medications or treatments you may be considering. They can help you understand any potential effects on your milk production or your baby's health. Always prioritize open communication with your healthcare team to ensure the best outcomes for you and your infant.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Additionally, if your child is under 12 years old, it's best to check with a doctor before use to ensure safety and proper dosage. Always prioritize your child's health by seeking 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 that may be present.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider will be the best resource for personalized advice. They can monitor for any potential side effects and make recommendations based on individual health status. Always prioritize open communication with your healthcare team to ensure the best outcomes.

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 should be used if you have renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

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, every individual is different, and your healthcare provider can help ensure that your treatment is safe and effective for you. Always feel free to ask questions and share your complete list of medications and any tests you may be undergoing.

Storage and Handling

To ensure the best quality and safety of your product, store it at room temperature. It's important to check the carton or tube crimp for the lot number and expiration date, as this information helps you confirm the product's validity and safety for use.

Always handle the product with care, and make sure to follow any additional instructions provided to maintain its integrity. Proper storage and attention to these details will help you use the product effectively and safely.

Additional Information

You should apply this product 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 you are dealing with external anal itching, it's best to first cleanse the area with mild soap and warm water, rinse thoroughly, and gently dry it by patting or blotting with toilet tissue or a soft cloth before applying the product.

FAQ

What is HydroCortisone used for?

HydroCortisone is used for temporary relief of itching associated with minor skin irritations and rashes, including conditions like eczema, insect bites, and poison ivy.

How should I apply HydroCortisone?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For external anal itching, cleanse the area with mild soap and warm water before application.

Are there any age restrictions for using HydroCortisone?

Do not use HydroCortisone on children under 2 years of age. Consult a doctor for children under 12 years.

What should I avoid while using HydroCortisone?

Do not use HydroCortisone in the eyes or insert it into the rectum using fingers or any device.

What should I do if my condition worsens?

Stop using HydroCortisone and consult a doctor if your condition worsens, persists for more than 7 days, or clears up and occurs again within a few days.

Can I use HydroCortisone if I am pregnant?

Do not use HydroCortisone if you are pregnant or planning to become pregnant without consulting a doctor.

What are the side effects of HydroCortisone?

For external use only, HydroCortisone may cause side effects if used improperly. Consult a doctor if you experience any adverse reactions.

How should I store HydroCortisone?

Store HydroCortisone at room temperature and check the carton or tube crimp for the lot number and expiration date.

Packaging Info

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

Packaging configurations for Western Family.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

HydroCortisone is a topical formulation containing 1% hydrocortisone, designed for the relief of itching. This anti-itch cream is presented in a dosage form of a cream, with a net weight of 1 ounce (28 grams). It is classified as a maximum strength preparation, indicating its potency in addressing symptoms associated with skin irritation.

Uses and Indications

This drug is indicated for the temporary relief of itching associated with minor skin irritations and rashes due to various conditions, including eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, seborrheic dermatitis, psoriasis, and external genital and anal itching.

Other uses of this product should only be undertaken under the advice and supervision of a healthcare professional.

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. In cases of external anal itching, it is recommended that adults cleanse the affected area with mild soap and warm water, followed by thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product.

The use of this product is not recommended for children under 2 years of age; consultation with a doctor is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor before use.

Contraindications

The product is contraindicated for use in the eyes due to the potential for irritation or damage to ocular tissues. Additionally, it should not be administered rectally, either manually or with any mechanical device or applicator, as this may lead to adverse effects or complications.

Warnings and Precautions

This product is intended for external use only. It is imperative that the product is not applied in or around the eyes, nor should it be administered rectally using fingers, mechanical devices, or applicators.

Prior to use, individuals should consult a healthcare professional if they are experiencing any of the following conditions: vaginal discharge, rectal bleeding, or diaper rash. These conditions may require further evaluation and management.

While using this product, it is crucial to adhere to the recommended dosage. Consultation with a healthcare provider is advised before exceeding the recommended dosage to avoid potential complications.

Users should discontinue use and seek medical advice if any of the following occur: the condition worsens, persists for more than 7 days, or resolves only to 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.

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.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for use in the eyes and should not be administered rectally, either by fingers or any mechanical device or applicator.

Before using this product, patients are advised to consult a doctor if they have a vaginal discharge, rectal bleeding, or diaper rash. While using this product, it is important to adhere to the recommended dosage and to seek medical advice before exceeding it.

Patients should discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition resolves and then recurs within a few days. It is also recommended that patients refrain from using any other hydrocortisone products without prior consultation with a healthcare professional.

Additionally, this product should be kept out of reach of children. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 Western Family (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Western Family.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the medication is not recommended, and a consultation with a doctor is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor prior to 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 use of this medication is contraindicated in pregnant patients. Women who are pregnant or planning to become pregnant should consult a healthcare professional prior to use. It is essential to evaluate the potential risks and benefits in these populations to ensure the safety of both the patient and the developing fetus.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects on lactation. Additionally, there is no available data on the excretion of this medication in breast milk or its potential effects on breastfed infants. Healthcare professionals should consider the absence of information when advising lactating mothers about the use of this medication.

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 prudent 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, it is imperative to seek medical assistance or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is essential.

Management of overdosage typically involves supportive care and symptomatic treatment. It is recommended that healthcare providers assess the patient's condition thoroughly and initiate appropriate interventions based on the clinical presentation.

Nonclinical Toxicology

No relevant information is available regarding teratogenic or non-teratogenic effects. Additionally, there is no pertinent data concerning nonclinical toxicology, animal pharmacology, or toxicology.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this product 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 informed that this product is not intended for use in the eyes and should not be administered rectally using fingers, mechanical devices, or applicators.

Healthcare providers should instruct patients to discontinue use and consult a doctor if their condition worsens, persists for more than 7 days, or if symptoms resolve only to recur within a few days. Patients should be cautioned against starting any other hydrocortisone product without prior consultation with a healthcare professional.

When using this product, patients should be advised to consult a doctor before exceeding the recommended dosage. Additionally, patients should be encouraged to seek medical advice before use if they experience vaginal discharge, rectal bleeding, or have a diaper rash.

Storage and Handling

The product is supplied in various packaging configurations, with specific NDC numbers available for identification. It should be stored at room temperature to maintain its integrity and efficacy. Healthcare professionals are advised to check the carton or tube crimp for the lot number and expiration date to ensure proper tracking and usage.

Additional Clinical Information

For patients aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. In cases of external anal itching, it is recommended that adults cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth prior to application.

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 Western Family, 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 Western Family, 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.