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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 29, 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 29, 2024
Manufacturer
Safeway
Registration number
M017
NDC root
21130-395
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

Hydrocortisone 1% Cream is an anti-itch cream that contains soothing aloe to help relieve discomfort. It is designed to temporarily alleviate itching caused by minor skin irritations, inflammation, and rashes. This cream is effective for various conditions, including eczema, psoriasis, insect bites, and reactions to poison ivy, oak, or sumac, as well as irritations from detergents, jewelry, cosmetics, soaps, and seborrheic dermatitis.

As the #1 doctor-recommended anti-itch active ingredient, Hydrocortisone 1% Cream provides maximum strength relief that lasts for up to 10 hours and absorbs quickly into the skin.

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 such as 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 temporarily relieve itching in external 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. This is suitable for adults and children who are 2 years old and older. However, if your child is under 2 years of age, it's important to consult a doctor before use.

For external anal and genital itching in adults, start by gently cleaning the area with mild soap and warm water, then rinse thoroughly. After cleaning, pat or blot the area dry 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 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 in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a doctor first. While using this product, make sure to avoid contact with your eyes, and do not exceed the recommended dosage unless your doctor advises you to do so. Additionally, do not insert the product directly into the rectum using your fingers or any device. Following these guidelines will help ensure your safety and the effectiveness of the treatment.

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 you experience worsening symptoms, if your condition persists for more than 7 days, or if you notice rectal bleeding, stop using the product and consult a doctor.

Additionally, this product is for external use only and should not be applied in the genital area if you have a vaginal discharge or used for diaper rash without consulting a doctor. Always keep it out of reach of children, and if 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 using it on internal areas, especially if you have a vaginal discharge or diaper rash—consult your doctor in these cases. When applying the product, be careful not to get it in your eyes, and only use the amount directed by your doctor. Do not insert it into the rectum using fingers or any devices.

If your condition worsens, symptoms last longer than 7 days, or if they improve and then return within a few days, stop using the product and consult your doctor. Additionally, if you experience rectal bleeding, seek medical advice immediately. If the product is swallowed, get emergency help or contact a Poison Control Center at 1-800-222-1222 right away.

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 can vary, but they may include unusual symptoms that require prompt attention. Always err on the side of caution and reach out for help if you suspect an overdose has occurred. Your safety is the top priority.

Pregnancy Use

If you are pregnant or planning to become pregnant, it's important to know that there are no specific guidelines or safety concerns mentioned regarding the use of hydrocortisone cream during pregnancy. The information available does not indicate any contraindications (situations where the product should not be used) or special precautions for pregnant individuals. Additionally, there are no recommended dosage modifications for those who are pregnant.

As always, it's best to consult with your healthcare provider before using any medication during pregnancy to ensure it is safe for you and your baby.

Lactation Use

You can use hydrocortisone cream while breastfeeding without specific warnings or recommendations against it. The information available does not indicate any concerns about the cream being passed into breast milk or posing risks to your nursing infant. However, as with any medication, it's always a good idea to consult with your healthcare provider if you have any questions or concerns about its use while breastfeeding.

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 for children aged 2 years and older. However, if your child is under 2 years old, it's important to consult a doctor before using the product.

For external anal and genital itching, adults should first clean the area with mild soap and warm water, then gently dry it before applying the treatment. This can also be done up to 3 to 4 times daily. If your child is under 12 years old, please consult a doctor for guidance before use. 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, it’s important to consult with a healthcare provider for personalized advice. 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 be adjusted 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. They can provide guidance based on your individual situation.

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 (liver issues).

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, 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 way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

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

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 of any components.

Additional Information

You should apply this medication topically to the affected area, using it no more than 3 to 4 times daily. If you're treating external anal and genital itching, it's best to first clean 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 medication. This will help ensure the best results.

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, including 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, then apply the cream.

Are there any precautions I should take when using this cream?

Avoid contact with the eyes, do not use more than directed, and do not apply directly into the rectum. Consult a doctor if you have a vaginal discharge or are treating diaper rash.

What should I do if my symptoms do not improve?

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 Hydrocortisone 1% Cream safe to use during pregnancy or while nursing?

The insert does not provide specific information regarding the use of Hydrocortisone 1% Cream during pregnancy or lactation. Consult your doctor for advice.

What should I do if I accidentally swallow the cream?

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

How should I store Hydrocortisone 1% Cream?

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

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 minor skin irritations. This cream contains hydrocortisone as the active ingredient, recognized as the #1 doctor-recommended anti-itch agent. The formulation is enhanced with soothing aloe to provide additional comfort. It is classified as a maximum strength preparation, offering prolonged efficacy with effects lasting up to 10 hours. The product is packaged in a net weight of 2 ounces (56 grams).

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, and sumac exposure, insect bites, reactions to detergents, jewelry, cosmetics, and soaps, as well as 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 recommended dosage for adults and children aged 2 years and older is to 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; a consultation with a healthcare professional is advised.

In cases of external anal and genital itching in adults, it is recommended 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 necessary before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; consultation with a healthcare professional is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a doctor's consultation is recommended in such cases.

Contact with the eyes must be avoided. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, it is contraindicated to administer the product directly into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is contraindicated for use in the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised. It is also not recommended for the treatment of diaper rash without prior medical consultation.

When utilizing this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended dosage and should not exceed the directed amount unless specifically instructed by a healthcare provider. Direct application into the rectum using fingers or any mechanical device or applicator is prohibited.

Patients should 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. Additionally, users should refrain from initiating any other hydrocortisone product without consulting a healthcare professional. Immediate medical attention is required if rectal bleeding occurs.

In the event of accidental ingestion, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately at 1-800-222-1222.

Side Effects

Patients using this product should be aware that it is for external use only. It is contraindicated for use in the genital area if there is a vaginal discharge, and patients are advised to consult a doctor in such cases. Additionally, this product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

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 doctor. Furthermore, 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 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. It is also crucial to seek medical advice if rectal bleeding occurs.

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 at 1-800-222-1222.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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

For the treatment of itching associated with skin irritation, inflammation, and rashes, the product is indicated for use in adults and children aged 2 years and older. The recommended application is to the affected area not more than 3 to 4 times daily. For children under 2 years of age, the product should not be used without consulting a doctor.

In cases of external anal and genital itching, adults are advised to clean the affected area with mild soap and warm water, rinsing thoroughly. The area should be gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. Similar to the previous indication, the application frequency is not more than 3 to 4 times daily. For children under 12 years of age, consultation with a doctor is recommended before use.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

There are no specific statements regarding the use of hydrocortisone cream during pregnancy. The prescribing information does not mention any safety concerns, contraindications, or precautions related to pregnancy. Additionally, no dosage modifications for pregnant individuals are provided. As such, there are no special precautions regarding the use of this product during pregnancy. Healthcare professionals should consider the absence of data when advising pregnant patients and weigh the potential benefits against any unknown risks.

Lactation

There are no specific warnings or recommendations regarding the use of hydrocortisone cream in lactating mothers. Additionally, the prescribing information does not provide statements concerning the potential for excretion of hydrocortisone in breast milk or any associated risks to breastfed infants.

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 this medication. Consequently, there are no 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. The national Poison Control Center can be reached at 1-800-222-1222.

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 of overdosage may include supportive care and symptomatic treatment, tailored to the individual patient's needs. It is imperative that healthcare providers remain vigilant and prepared to implement necessary interventions based on the clinical presentation of the patient.

Nonclinical Toxicology

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

Postmarketing Experience

Postmarketing experience has revealed reports of skin irritation and allergic reactions associated with the use of hydrocortisone cream. Additionally, other adverse effects have been documented. These events were reported voluntarily or identified through surveillance programs.

Patient Counseling

Healthcare providers should advise patients to keep this medication 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 not to use this product in the genital area if they have a vaginal discharge and to consult a doctor in such cases. Additionally, it is important to emphasize that this medication is not intended for the treatment of diaper rash, and patients should seek medical advice if they have such a condition.

Healthcare providers should instruct patients 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. Patients should also be advised not to start using any other hydrocortisone product without first consulting a doctor. Furthermore, if rectal bleeding occurs, patients should stop using the product and seek medical attention.

While using this medication, patients should be cautioned to avoid contact with the eyes. It is essential to inform patients not to exceed the recommended dosage unless directed by a healthcare professional. Lastly, patients should be advised against inserting 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 20-25°C (68-77°F) to maintain its integrity and efficacy. Proper storage conditions should be ensured to prevent any degradation of the product.

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 in adults, it is advised to clean 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 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.