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Refuge Hc

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Active ingredient
Hydrocortisone .01 mg/1 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 2011
Label revision date
August 18, 2011
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone .01 mg/1 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 2011
Label revision date
August 18, 2011
Manufacturer
CoValence Inc.
Registration number
part348
NDC root
66915-531
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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

You can use this medication for temporary relief of itching and discomfort caused by minor skin irritations, inflammation, and rashes. It is designed to help soothe your skin and provide comfort when you are experiencing these types of issues. If you have any concerns or questions about its use, it's always a good idea to consult with a healthcare professional.

Uses

You can use this medication for temporary relief from itching and discomfort caused by minor skin irritations, inflammation, and rashes. It’s designed to help soothe your skin and alleviate any associated discomfort.

Rest assured, there are no concerns regarding teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects with this medication. This makes it a safe option for managing your skin issues.

Dosage and Administration

You should apply the medication to the affected area, making sure to do this no more than 3 to 4 times each day. This means you can use it several times throughout the day, but be careful not to exceed the recommended amount.

For best results, ensure that you are applying it directly to the area that needs treatment. Following these guidelines will help you manage your condition effectively.

What to Avoid

It’s important to be aware of certain precautions when using this medication. First, do not use it if you are caring for a child under 12 years of age; please consult a physician for guidance. Additionally, always keep this medication out of reach of children. If it is accidentally swallowed, seek medical help or contact a Poison Control Center immediately.

By following these guidelines, you can help ensure safety and avoid potential misuse or dependence (a condition where the body becomes reliant on a substance). Your health and well-being are the top priority, so please take these warnings seriously.

Side Effects

When using this medication, it's important to remember that it is for external use only, so you should avoid getting it in your eyes. If you do experience any irritation or discomfort, please rinse your eyes with water immediately. Always follow the instructions provided to ensure safe use.

Warnings and Precautions

This product is for external use only, so be sure to avoid getting it in your eyes. It's important to keep it out of reach of children. If a child under 12 years old needs to use it, please consult a physician first. If the product is swallowed, seek medical help or contact a Poison Control Center immediately.

Always prioritize safety by following these guidelines. If you have any concerns or questions about using this product, don’t hesitate to reach out to your healthcare provider.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While the specific signs of an overdose are not detailed, common symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's crucial to provide them with as much information as possible about the substance taken and the amount, if known. Remember, acting quickly can make a significant difference in your health and safety.

Pregnancy Use

There is currently no specific information available about the use of REFUGE HC - hydrocortisone cream during pregnancy. This means that safety concerns, dosage adjustments, or any special precautions for pregnant individuals have not been addressed in the drug insert.

If you are pregnant or planning to become pregnant, it is important to consult with your healthcare provider before using this cream. They can help you understand any potential risks and determine the best course of action for your situation.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there are no known concerns about the product being passed into breast milk or any associated risks for your infant. This means you can use the product without worrying about its effects on your milk production or your baby's health.

Pediatric Use

If your child is under 12 years old, it's important not to use this medication without first consulting a physician (a medical doctor). For children aged 12 and older, you can apply the medication to the affected area, but be sure to limit this to no more than 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

While there is no specific information about the use of REFUGE HC - hydrocortisone cream in older adults, it’s important to approach its use with caution. Since the drug insert does not mention any dosage adjustments or safety concerns for elderly patients, you should consult with a healthcare professional before using this cream. They can provide guidance tailored to your individual health needs and any other medications you may be taking. Always prioritize safety and ensure that any treatment is appropriate for your situation.

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 is safe and effective, especially if you have any concerns about your kidney health.

Hepatic Impairment

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

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

Drug Interactions

It's great to know that there are no known 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 start. This open communication helps prevent any potential issues and supports your overall well-being.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature. It's important to keep it out of reach of children to prevent any accidental ingestion or misuse. Once you open the product, be sure to discard it after use to maintain safety and hygiene. Following these simple guidelines will help you use the product safely and effectively.

Additional Information

You should apply this medication topically to the affected area, and it can be used by adults and children aged 12 years or older. Make sure to limit the application to no more than 3 to 4 times a day for best results. There is no additional information available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is the primary use of this drug?

This drug is used for temporary relief of itching and discomfort associated with minor skin irritations, inflammation, and rashes.

What is the recommended dosage for adults and children 12 years or older?

You should apply the drug to the affected area no more than 3 to 4 times daily.

Are there any contraindications for this drug?

Yes, do not use this drug in children under 12 years of age without consulting a physician.

What should I do if the drug is swallowed?

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

What precautions should I take when using this drug?

This drug is for external use only, and you should avoid contact with eyes. Keep it out of reach of children.

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

There are no specific warnings or recommendations regarding the use of this product during pregnancy or lactation.

How should I store this drug?

Store the drug at room temperature and discard it after opening.

Packaging Info

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

Packaging configurations for Refuge Hc.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

No specific information regarding the Description section for SPL code 34089-3 is provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of itching and discomfort associated with minor skin irritations, inflammation, and rashes.

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

Dosage and Administration

Adults and children 12 years of age or older should apply the medication to the affected area no more than 3 to 4 times daily. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects. The medication should be applied using clean hands or an appropriate applicator to maintain hygiene and prevent contamination of the affected area.

Contraindications

Use is contraindicated in children under 12 years of age; consultation with a physician is advised prior to use in this population.

Additionally, the 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.

Warnings and Precautions

For external use only; contact with eyes should be avoided to prevent irritation or injury.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay. The use of this product is not recommended for children under 12 years of age unless directed by a physician.

In cases of ingestion, prompt action is necessary; individuals should seek emergency medical help or reach out to a Poison Control Center immediately.

Side Effects

Patients should be informed that the product is for external use only and must avoid contact with the eyes. Adverse reactions associated with the use of this product may occur, and it is essential for patients to be aware of these potential risks.

In clinical trials and postmarketing experiences, specific adverse reactions have been reported, although detailed frequency data is not provided. Patients are advised to monitor for any unexpected reactions and to consult healthcare professionals if they experience any adverse effects.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary.

Packaging & NDC

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

Packaging configurations for Refuge Hc.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a physician. For adolescents and children aged 12 years and older, the recommended application is to the affected area no more than 3 to 4 times daily.

Geriatric Use

There is no specific information regarding the use of REFUGE HC - hydrocortisone cream in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects is advisable, given the lack of targeted data for this population.

Pregnancy

There is no specific information regarding the use of REFUGE HC - hydrocortisone cream during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes. It is advisable to exercise caution and consult relevant clinical guidelines when treating pregnant patients with this medication.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there are no statements concerning the potential for excretion in breast milk or any associated risks to breastfed infants during lactation.

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 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 monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide further management and treatment options.

Documentation of the incident, including the substance involved, the amount taken, and the time of ingestion, 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 compound in these areas.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

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

Additionally, it is important for healthcare providers to inform patients that this medication is not recommended for use in children under 12 years of age without prior consultation with a physician. This precaution helps ensure the safety and well-being of younger patients.

Storage and Handling

The product is supplied in a configuration that ensures optimal usability. It should be stored at room temperature, away from direct sunlight and moisture. To maintain safety, it is essential to keep the product out of reach of children. Once opened, the product must be discarded to ensure proper safety and efficacy.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency of no more than 3 to 4 times daily for adults and children aged 12 years or older. 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 Refuge Hc, 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 Refuge Hc, 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.