Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Western Family

Last content change checked dailysee data sync status

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 1989
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 1989
Label revision date
March 14, 2013
Manufacturer
Western Family Foods Inc
Registration number
part348
NDC root
55312-063
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 topical cream that contains 1% hydrocortisone, designed to provide temporary relief from itching associated with minor skin irritations and rashes. This cream is particularly effective for conditions such as eczema, insect bites, poison ivy, poison oak, and poison sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and external genital and anal itching.

In addition to its anti-itch properties, Hydrocortisone is formulated with 12 moisturizers to help soothe and hydrate the skin. It is important to use this product as directed, and for any other uses, you should consult with a doctor for guidance.

Uses

You can use this product for temporary relief from itching caused by various minor skin irritations and rashes. This includes conditions like eczema, insect bites, and reactions to plants such as 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 for advice and supervision.

Dosage and Administration

When using this medication, you should apply 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. For children under 2 years old, it’s important not to use this product without first consulting a doctor. If you are an adult, it’s best to start by gently cleaning the affected area with mild soap and warm water, then rinse it thoroughly.

After cleaning, make sure to gently dry the area by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If you are caring for a child under 12 years of age, please consult a doctor for guidance on the appropriate use of this product.

What to Avoid

You should avoid using this product in your eyes or inserting it into the rectum using fingers or any mechanical device or applicator. If your condition worsens, lasts longer than 7 days, or clears up only to return within a few days, stop using the product and consult your doctor. It's important not to start any other hydrocortisone product without first discussing it with your healthcare provider.

Side Effects

You should be aware that this product is for external use only and should not be applied to the eyes or inserted into the rectum using fingers or any devices. Before using it, consult a doctor if you have a vaginal discharge, rectal bleeding, or diaper rash.

If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using the product and seek medical advice. Additionally, keep this product out of reach of children, and if it is swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is 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 and consult your doctor if you feel the need to exceed it. If your condition worsens, does not improve after 7 days, or clears up only to return within a few days, stop using the product and contact your doctor. Avoid starting any other hydrocortisone product without consulting a healthcare professional first.

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 this 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.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for you. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When considering the use of this product during pregnancy, it's important to note that there are no specific statements or guidelines provided regarding its safety or use in pregnant individuals. This means that there is no information available about potential risks, necessary dosage adjustments, or special precautions you should take while pregnant. Additionally, there are no contraindications (conditions that would prevent you from using the product) mentioned for pregnant individuals.

Given the lack of information, it is advisable to consult with your healthcare provider before using this product if you are pregnant or planning to become pregnant. They can help you weigh the potential benefits and risks based on your individual circumstances.

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 may not find detailed information about how certain medications or treatments could affect you or your baby.

If you have concerns about breastfeeding while taking any medication, it's always best to consult with your healthcare provider. They can provide personalized advice based on your situation and help ensure the safety and well-being of both 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 advisable 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

When it comes to using HydroCortisone Plus 12 Moisturizers, there is no specific information available about its use in older adults. This means that if you or a loved one is considering this product, it’s important to approach it with caution, especially if there are any underlying health concerns.

Always consult with a healthcare provider before starting any new treatment, as they can provide personalized advice based on individual health needs and conditions. This is particularly important for older adults, who may have different sensitivities or reactions to medications and treatments.

Renal Impairment

If you have kidney problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or safety considerations for your condition. This means that there are no tailored guidelines for how this medication may affect you if your kidneys are not functioning properly.

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

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking. In this case, there are no specific drug interactions or laboratory test interactions noted, which means that this medication is generally considered safe to use alongside other treatments and tests. However, every individual is different, and your healthcare provider can help ensure that your overall treatment plan is safe and effective for you. Always feel free to ask questions or express any concerns you may have regarding your medications or tests.

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.

Who should not use HydroCortisone?

Children under 2 years of age should not use HydroCortisone without consulting a doctor. Additionally, do not use it in the eyes or rectum.

How should I apply HydroCortisone?

Adults and children 2 years and older should apply it to the affected area no more than 3 to 4 times daily, after cleansing and drying the area.

What should I do if my condition worsens?

If your condition gets worse, persists for more than 7 days, or clears up and occurs again within a few days, stop using HydroCortisone and consult a doctor.

Is HydroCortisone safe to use during pregnancy?

The provided information does not mention specific safety concerns or contraindications regarding the use of HydroCortisone during pregnancy.

What are the side effects of HydroCortisone?

For external use only, HydroCortisone may cause irritation. If you experience worsening symptoms or other concerns, consult a doctor.

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 product is presented in the form of a cream, specifically labeled as "Anti-Itch CREAM PLUS," and is formulated with 12 moisturizers to enhance skin hydration. The net weight of the product is 1 ounce (28 grams), and it is classified as a maximum strength formulation, indicating its potency in providing symptomatic relief.

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, jewelry, 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. Prior to application, it is recommended that the affected area be cleansed with mild soap and warm water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the product.

For children under 2 years of age, the product should not be used without consulting a doctor. Additionally, for children under 12 years of age, it is advised to consult a doctor prior to use.

Contraindications

The product is contraindicated for use in the eyes and for rectal administration via fingers, mechanical devices, or applicators.

If the condition worsens, persists for more than 7 days, or resolves and recurs within a few days, discontinue use and consult a healthcare professional. The initiation of any other hydrocortisone product should only occur after medical consultation.

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 symptoms may indicate underlying issues that require medical evaluation.

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

Users must discontinue use and seek medical advice if any of the following occur: the condition worsens, persists for more than seven days, or resolves only to recur within a few days. It is important not to initiate the use of any other hydrocortisone products without prior consultation with a healthcare professional.

To ensure safety, this product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

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 healthcare professional if they have a vaginal discharge, rectal bleeding, or diaper rash.

Patients should discontinue use and seek medical advice if their condition worsens, persists for more than 7 days, or if the condition clears up and recurs within a few days. It is important not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

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

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been noted in the available data. 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 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 use of this medication is not recommended, and a consultation with a healthcare professional is advised. Additionally, for children under 12 years of age, it is important to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of HydroCortisone Plus 12 Moisturizers in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this product to elderly patients. It is advisable to monitor for any potential adverse effects or changes in response to treatment, as the pharmacokinetics and safety profile may differ in this population. Additionally, clinicians should consider individual patient factors, including comorbidities and concurrent medications, when determining the appropriateness of this product for geriatric patients.

Pregnancy

There are no specific statements regarding the use of this product during pregnancy. Additionally, no information is provided about safety concerns, dosage modifications, or special precautions related to its use in pregnant patients. Furthermore, there are no contraindications in pregnancy mentioned in the available data. Healthcare professionals should consider the lack of information when prescribing this product to women of childbearing potential and weigh the potential risks and benefits.

Lactation

There are no specific statements regarding the use of this medication in nursing mothers or its effects during 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 advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the prescribing information.

Overdosage

In the event of an overdosage, immediate medical assistance is crucial. If the substance is ingested, healthcare professionals should advise patients or caregivers to seek medical help or contact a Poison Control Center without delay.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved; therefore, a thorough assessment by a medical professional is recommended to determine the appropriate course of action.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are advised to ensure patient safety and effective resolution of any complications arising from the 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 in these areas limits the understanding of the compound's safety profile 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 product out of reach of children to prevent accidental ingestion. In the event of swallowing the product, patients should seek medical help 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. They should be instructed to stop using the product and consult a doctor if their condition worsens, persists for more than 7 days, or if the condition improves and then recurs within a few days. It is important to note that patients should not begin using any other hydrocortisone product without first consulting a doctor.

When using this product, patients should be cautioned against exceeding the recommended dosage and should consult a doctor prior to doing so. Additionally, patients should be advised 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 efficacy. For traceability, healthcare professionals are advised to refer to the carton or tube crimp for the lot number and expiration date. Proper handling and storage conditions are essential to ensure the integrity of the product throughout its shelf life.

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.