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Signature Care Hydrocortisone

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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 2015
Label revision date
October 3, 2024
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 2015
Label revision date
October 3, 2024
Manufacturer
Safeway
Registration number
M017
NDC root
21130-369
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 1% Cream is a maximum strength anti-itch cream designed to provide fast relief for dry, itchy skin. It is the #1 doctor-recommended active ingredient for itch relief and works by temporarily alleviating itching associated with minor skin irritations, inflammation, and rashes. This cream is safe for sensitive skin and can help heal conditions such as eczema, psoriasis, poison ivy, insect bites, and reactions to various irritants.

In addition to relieving itchiness, Hydrocortisone 1% Cream calms, nourishes, and hydrates the skin, making it an effective choice for those seeking intensive healing. It is important to use this product as directed, and for any other uses, consult with a doctor.

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 like eczema, psoriasis, and reactions to poison ivy, oak, or sumac. It also helps soothe itching from insect bites, as well as irritations caused by detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

Additionally, this product can relieve external itching in the anal and genital areas. For any other uses, it's important to consult with your doctor for guidance 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 to 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 important to consult a doctor before using this treatment.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again up to 3 to 4 times daily. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash or in the genital area if you have a vaginal discharge—please consult your doctor in these cases. Additionally, avoid contact with your eyes and do not exceed the recommended dosage unless directed by your healthcare provider.

For your safety, never insert the product directly into the rectum using your fingers or any device. Following these guidelines will help prevent misuse and ensure you use the product as intended.

Side Effects

When using this product, it's important to be aware of some potential side effects and precautions. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If your condition worsens, persists for more than 7 days, or clears up only to return shortly after, stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

This product is for external use only and should not be used for diaper rash or in the genital area if you have a vaginal discharge without consulting a doctor. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center right away.

Warnings and Precautions

This product is for external use only, so please avoid using it on internal areas. Do not use it for treating diaper rash, and if you have a vaginal discharge, consult your doctor before applying it in the genital area.

If your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and talk to your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately.

In case of accidental swallowing, it’s important to get emergency medical help or contact a Poison Control Center right away. Always prioritize your health and safety by following these guidelines.

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 seek assistance if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to avoid using this medication. The potential risks to your developing baby have not been established, so it’s crucial to consult your doctor before considering its use. Your healthcare provider can help you understand the safest options for your health and your baby's well-being.

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 statements indicating that this product is excreted in breast milk or that it poses any risk to your infant. This means you can use it without special concerns about its effects on your milk production or your baby's health.

Pediatric Use

If your child is experiencing itching from skin irritation, inflammation, or rashes, you can apply the treatment to the affected area up to 3 to 4 times a day if they are 2 years old or older. However, if your child is under 2 years of age, it’s important to consult a doctor before using this treatment.

For external anal and genital itching, it's recommended that you speak with a doctor if your child is under 12 years old. Always prioritize your child's safety and seek professional advice when needed.

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 there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the usual recommendations for monitoring or safety considerations for patients with renal impairment (kidney issues) are not provided.

Always consult your healthcare provider for personalized advice and to ensure that any medications you take are safe and appropriate for your kidney health. They can help you understand how your condition may affect your treatment plan.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or precautions related to your condition. This means that there are no tailored recommendations for how the 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 about taking this medication with your liver condition. They can help ensure that your treatment is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can provide the best care tailored to your needs.

Always feel free to ask questions about how different medications might affect each other or any tests you may undergo. Your health and safety are the top priority, and discussing these details can help prevent any potential issues.

Storage and Handling

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

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, follow them carefully to ensure safety and compliance.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. For issues like external anal and genital itching, adults can also apply it in the same manner.

If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and consult a doctor. Additionally, do not start using any other hydrocortisone product without first checking with your doctor. If the medication is swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is Hydrocortisone 1% Cream used for?

Hydrocortisone 1% Cream is used to temporarily relieve itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, psoriasis, and insect bites.

How should I apply Hydrocortisone 1% Cream?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For external anal and genital itching, clean the area first and then apply the cream.

Are there any contraindications for using this cream?

Do not use Hydrocortisone 1% Cream for diaper rash or in the genital area if you have a vaginal discharge. Consult a doctor for advice.

What should I do if my condition worsens?

Stop using the cream and consult a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is it safe to use during pregnancy?

Do not use Hydrocortisone 1% Cream during pregnancy unless advised by a doctor, as the risk to the fetus is not established.

What are the side effects of Hydrocortisone 1% Cream?

Common side effects may include skin irritation. If you experience severe reactions or if the condition worsens, seek medical advice.

How should I store Hydrocortisone 1% Cream?

Store the cream at 20°-25°C (68°-77°F) to maintain its effectiveness.

Can children use Hydrocortisone 1% Cream?

Children under 2 years of age should not use this cream without consulting a doctor. For children under 12 years, consult a doctor for external anal and genital itching.

Packaging Info

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

Packaging configurations for Signature Care Hydrocortisone.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Hydrocortisone 1% Cream is a topical formulation designed for the relief of itching associated with various skin conditions, including eczema and psoriasis. The active ingredient, hydrocortisone, is recognized for its anti-inflammatory properties, effectively addressing inflammation, irritation, and redness. This cream features an intensive healing formula that provides maximum strength relief, lasting up to 10 hours. It is formulated to calm, nourish, and hydrate the skin, making it suitable for sensitive skin types. The product is packaged in a net weight of 1 oz (28 g).

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 eczema, psoriasis, poison ivy, oak, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis. Additionally, it provides temporary relief for external anal and genital 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 following dosage and administration guidelines are recommended:

Adults and children aged 2 years and older should 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; consultation with a healthcare professional is advised.

In cases of external anal and genital itching in adults, it is advisable to first clean the affected area with mild soap and warm water, ensuring thorough rinsing. After cleansing, the area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. The medication should then 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

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised. Additionally, the use of this product in the genital area is contraindicated in patients with vaginal discharge; a healthcare professional should be consulted in such cases.

Contact with the eyes should be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Direct application into the rectum using fingers or any mechanical device or applicator is also contraindicated.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; healthcare professionals should advise patients to consult a doctor for appropriate alternatives. Additionally, it should not be applied in the genital area if there is a vaginal discharge; again, a consultation with a healthcare provider is recommended.

Patients should be instructed to discontinue use and seek medical advice if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. It is important to note that patients should not initiate the use of any other hydrocortisone product without prior consultation with a healthcare professional. Immediate medical attention is required if rectal bleeding occurs.

In cases of accidental ingestion, patients should seek emergency medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash and should not be applied in the genital area if there is a vaginal discharge; in such cases, consultation with a healthcare provider is advised.

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

Patients are advised to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Furthermore, if rectal bleeding occurs, medical advice should be sought immediately.

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 without delay.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

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

Packaging configurations for Signature Care Hydrocortisone.
Details

Pediatric Use

Pediatric patients aged 2 years and older may apply the medication to the affected area for itching associated with skin irritation, inflammation, and rashes, not exceeding 3 to 4 times daily. For children under 2 years of age, use is not recommended without consulting a doctor.

In cases of external anal and genital itching, it is advised that children under 12 years of age consult a doctor before use.

Geriatric Use

There is no specific information 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, given the lack of targeted data for this population.

Pregnancy

The use of this medication is contraindicated in pregnant patients. The risk to the fetus has not been established, and therefore, it is essential for women who are pregnant or planning to become pregnant to consult a healthcare professional prior to use. Healthcare providers should carefully evaluate the potential risks and benefits when considering treatment options for pregnant patients.

Lactation

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

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the text. Therefore, healthcare professionals should exercise caution and consider individual patient factors when prescribing to this population. Regular assessment of renal function may be warranted to ensure safe and effective use of the medication in patients with reduced kidney function.

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 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 should include supportive care and symptomatic treatment as necessary. Continuous assessment of the patient's condition is recommended to address any complications that may arise.

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 these contexts.

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. Instruct patients that if the product is swallowed, they should seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for the treatment of diaper rash and that they should consult a doctor for appropriate alternatives. Additionally, healthcare providers should caution patients against using the product in the genital area if they have a vaginal discharge, and to seek medical advice in such cases.

Patients must be advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. They should also be instructed not to use any other hydrocortisone product without first consulting a doctor.

It is important to inform patients to stop using the product and seek medical attention if they experience rectal bleeding. While using this product, patients should be reminded to avoid contact with the eyes.

Healthcare providers should emphasize that patients must not exceed the recommended dosage unless directed by a doctor. Furthermore, patients should be instructed not to insert the product directly into the rectum using fingers or any mechanical device or applicator.

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 a controlled temperature range of 20° to 25°C (68° to 77°F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept within the specified temperature limits.

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 2 years and older. For external anal and genital itching, adults should also adhere to this application frequency.

Patients should be counseled to discontinue use and consult a healthcare professional if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients are advised not to start any other hydrocortisone product without consulting a doctor. In the event of accidental ingestion, immediate medical assistance or contact with a Poison Control Center is necessary.

Drug Information (PDF)

This file contains official product information for Signature Care 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 Signature Care 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.

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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.