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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
Lotion
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
February 6, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Lotion
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 2018
Label revision date
February 6, 2025
Manufacturer
Safeway
Registration number
M017
NDC root
21130-166
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% is an anti-itch lotion designed to provide temporary relief from itching caused by minor skin irritations, rashes, and inflammation due to conditions like eczema. This lotion is clinically proven to moisturize your skin for up to 24 hours and contains seven intensive moisturizers, along with botanicals and antioxidant vitamins A, C, and E, to help soothe and nourish your skin.

As the #1 doctor-recommended active ingredient for itch relief, Hydrocortisone 1% offers a maximum strength formulation that delivers fast and lasting relief from discomfort. It's important to use this product as directed and consult with a doctor for any other uses.

Uses

You can use this product to temporarily relieve itching caused by minor skin irritations, rashes, and inflammation related to eczema. It's important to note that while this product can help with these specific issues, any other uses should only be done under the guidance and supervision of a doctor. Always consult with a healthcare professional if you have questions or concerns about your skin condition.

Dosage and Administration

If you or your child is 2 years of age or older, you can apply the medication to the affected area up to 3 to 4 times a day. Make sure to follow this guideline to ensure the best results.

For children under 2 years old, it’s important to consult with a doctor before using the medication. This will help ensure safety and proper care for your little one. Always follow your healthcare provider's advice for the best outcomes.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; if you have concerns about this condition, please consult your doctor. Additionally, avoid getting the medication in your eyes, as this can cause irritation. Always follow the dosage instructions carefully and do not exceed the recommended amount unless your doctor advises you to do so. Your safety is a priority, so if you have any questions or uncertainties, reach out to your healthcare provider.

Side Effects

This product is for external use only. If your condition worsens, or if symptoms last more than 7 days or improve and then return within a few days, stop using it and consult your doctor. It's important not to start any other hydrocortisone product without medical advice.

If the product is swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any areas that may come into contact with your eyes. It's important not to use more than the recommended amount unless your doctor advises you to do so.

If you accidentally swallow this product, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. You should also stop using the product and consult your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, do not start using any other hydrocortisone product without first speaking to your doctor.

Overdose

If you or someone else has swallowed too much of this medication, it’s important to seek medical help immediately. You can contact a Poison Control Center at 1-800-222-1222 for guidance.

Signs of an overdose may include unusual symptoms, but specific details on these symptoms are not provided here. 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

If you are pregnant or planning to become pregnant, it's important to be cautious with hydrocortisone lotion, as its safety during pregnancy has not been established. Before using this medication, you should consult your doctor to discuss any potential risks and to ensure it is appropriate for your situation.

Using hydrocortisone lotion while pregnant should only be done under your doctor's guidance. The potential risks to your fetus (unborn baby) are not clearly defined, so exercising caution is essential. Always prioritize open communication with your healthcare provider regarding any medications you consider during this time.

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 concern for affecting your milk production or your baby's health. Always consult with your healthcare provider if you have any questions or concerns about your specific situation.

Pediatric Use

If your child is under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply it to the affected area, but be sure not to exceed 3 to 4 applications per day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that if you or a loved one is an older adult considering this medication, it’s important to consult with a healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken. Always prioritize open communication with your healthcare team to ensure safe and effective treatment.

Renal Impairment

If you have kidney problems, it's important to know that the information provided does not include specific guidelines for dosage adjustments, special monitoring, or safety considerations related to renal impairment (kidney issues). This means that there are no tailored recommendations for how your treatment may need to change based on your kidney function.

Always consult your healthcare provider for personalized advice and to ensure that your treatment plan is safe and effective for your specific situation. They can help monitor your kidney health and make any necessary adjustments to your medications.

Hepatic Impairment

If you have liver problems, it's important to know that the information provided does not include specific guidelines about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no detailed recommendations available for how your liver health might affect the use of this medication.

Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and appropriate for your liver health. They can help you understand how to manage your condition effectively while considering any medications you may need.

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 monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

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 its effectiveness and safety.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. Always follow any specific disposal instructions provided to ensure safe and responsible disposal.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling information.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% is an anti-itch lotion that temporarily relieves itching associated with minor skin irritations, rashes, and inflammation due to eczema.

How often can I apply Hydrocortisone 1%?

Adults and children 2 years of age and older can apply it to the affected area not more than 3 to 4 times daily.

Is Hydrocortisone 1% safe for children under 2 years?

For children under 2 years of age, you should ask a doctor before use.

Are there any contraindications for using Hydrocortisone 1%?

Do not use it for the treatment of diaper rash and consult a doctor if you are pregnant or planning to become pregnant.

What should I do if I accidentally swallow Hydrocortisone 1%?

If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

What precautions should I take when using Hydrocortisone 1%?

Avoid contact with eyes and do not use more than directed unless told to do so by a doctor.

What should I do if my condition worsens while using Hydrocortisone 1%?

Stop use and ask a doctor if your condition worsens, if symptoms persist for more than 7 days, or if they clear up and occur again within a few days.

What are the storage conditions for Hydrocortisone 1%?

Store Hydrocortisone 1% at 20-25°C (68-77°F).

Does Hydrocortisone 1% contain any moisturizers?

Yes, it contains 7 intensive moisturizers and is clinically proven to moisturize for 24 hours.

Can I use Hydrocortisone 1% during pregnancy?

The safety of Hydrocortisone 1% during pregnancy has not been established, and its use should only be under the advice and supervision of a doctor.

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% is an anti-itch lotion formulated for the relief of eczema and itchy, dry skin. This product is classified as a maximum strength formulation, designed to provide fast and lasting itch relief. It is clinically proven to moisturize for up to 24 hours, incorporating seven intensive moisturizers to enhance skin hydration. The formulation also includes botanicals and antioxidant vitamins A, C, and E, contributing to its skin-soothing properties. The product is packaged in a net weight of 3.5 ounces (99 grams).

Uses and Indications

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

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

Dosage and Administration

For adults and children aged 2 years and older, the recommended application is to the affected area not more than 3 to 4 times daily. It is important to ensure that the application is performed with clean hands and that the affected area is properly prepared prior to administration.

For children under 2 years of age, it is advised to consult a physician before use to determine the appropriate course of action.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, contact with the eyes should be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a physician.

Warnings and Precautions

For external use only. It is imperative that healthcare professionals advise patients to avoid contact with the eyes to prevent irritation or injury. Patients should be instructed not to exceed the recommended dosage unless specifically directed by a physician.

In the event of accidental ingestion, immediate medical assistance should be sought. Patients are encouraged to contact a Poison Control Center at 1-800-222-1222 for guidance.

Healthcare providers should counsel patients to discontinue use and consult a physician if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, patients should refrain from using any other hydrocortisone products without prior consultation with a healthcare professional.

Side Effects

Patients should be aware that the product is for external use only. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then occur again within a few days, patients are advised to stop use and consult a doctor. It is also important to refrain from using any other hydrocortisone product without prior consultation with a healthcare professional.

In cases where the product is swallowed, immediate medical assistance should be sought, or patients should contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

There are no specific drug interactions identified for the product. Additionally, no laboratory test interactions have been reported. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the available data.

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 under 2 years of age should consult a healthcare professional before use. For children aged 2 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 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The safety of hydrocortisone lotion during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional prior to use. It is recommended that hydrocortisone lotion be used during pregnancy only under the advice and supervision of a doctor.

While specific risks to the fetus are not clearly defined, caution is advised when considering the use of this medication in pregnant individuals. Healthcare providers should weigh the potential benefits against any unknown risks when prescribing hydrocortisone lotion to women of childbearing potential.

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 during the use of this product in 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 clinical trials for this medication. Consequently, there is no available information regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted based on clinical judgment.

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 without delay. It is recommended to contact a Poison Control Center at 1-800-222-1222 for guidance on the appropriate steps to take.

Prompt intervention is essential to mitigate potential adverse effects associated with overdosage. Symptoms may vary depending on the specific substance involved, and healthcare providers should be prepared to assess and manage these symptoms accordingly.

Management procedures may include supportive care and symptomatic treatment, tailored to the individual patient's needs. Continuous monitoring and evaluation are recommended 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 limits the assessment of potential risks associated with the use of the compound in question.

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 assistance or contact a Poison Control Center immediately at 1-800-222-1222.

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. It is important to instruct patients to avoid contact with the eyes while using this product.

Healthcare providers should emphasize that patients must not exceed the recommended dosage unless directed by a physician. Patients should be counseled 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. Additionally, patients should be advised not to start using any other hydrocortisone product without first consulting their doctor.

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 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent exposure to extreme temperatures, which may compromise the product's quality.

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. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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.

Learn more in our Editorial Policy

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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.