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Signature Care Anti Itch

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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
September 23, 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
September 23, 2024
Manufacturer
Safeway
Registration number
M017
NDC root
21130-278
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 a maximum strength anti-itch cream designed to provide temporary relief from itching caused by minor skin irritations, inflammation, and rashes. It is commonly used to treat various conditions, including eczema, insect bites, poison ivy, and dermatitis, as well as itching in external anal and genital areas.

This cream works by reducing inflammation and soothing the skin, helping to heal rashes for healthier skin. It is the #1 doctor-recommended active ingredient for relieving itchiness, making it a trusted choice for those seeking relief from uncomfortable skin conditions.

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, insect bites, and reactions to plants like poison ivy, oak, or sumac. It can also help soothe irritation from soaps, detergents, cosmetics, and jewelry. Additionally, it offers relief for external anal and genital itching, as well as conditions like seborrheic dermatitis and psoriasis.

For any other uses, it's important to consult with your doctor to ensure it's appropriate for your situation.

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 best to consult a doctor before use.

For external itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, rinsing thoroughly. After gently drying the area by patting or blotting with toilet tissue or a soft cloth, you can apply the medication 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 to avoid potential issues. 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. Additionally, be careful to avoid contact with your eyes.

When using this product, follow the directions closely. Do not use more than what is recommended unless your doctor advises otherwise. Also, avoid inserting the product directly into the rectum using your fingers or any devices. Taking these precautions can 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 warnings. You should avoid contact with your eyes and not use it more than directed unless advised by a doctor. If you experience worsening symptoms, persistent issues for more than 7 days, or if symptoms clear up and then return within a few days, stop using the product and consult a doctor. Additionally, if you notice any rectal bleeding, seek medical advice immediately.

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

Warnings and Precautions

This product is for external use only, so please avoid using it on any 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 your fingers or any device.

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 right away at 1-800-222-1222.

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 the safety of hydrocortisone 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 while pregnant should only be done under the guidance and supervision of a healthcare professional. The potential risks to your fetus are not clearly defined, so exercising caution is advised. Always prioritize open communication with your healthcare provider regarding any medications you may need.

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 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.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. Since older adults may have different health needs and may be taking multiple medications, it’s always a good idea to consult with a healthcare provider before starting any new medication. They can help ensure that the treatment is safe and appropriate for your individual health situation.

If you or a loved one is an older adult, be sure to discuss any concerns about potential side effects or interactions with other medications you may be taking. Your healthcare provider can provide guidance tailored to your specific needs.

Renal Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your health situation. They can help you understand how to manage your treatment effectively while considering your kidney health.

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 may affect you if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

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

Storage and Handling

To ensure the best 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, make sure to do so in a clean environment to avoid contamination. Always follow any specific instructions provided for use to ensure safety and effectiveness. If you have any questions about disposal or further handling, please refer to the guidelines provided with your product.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times daily if you are an adult or a child aged 2 years and older. For external anal and genital itching, adults should also follow the same application frequency.

It's important to keep this medication out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately at 1-800-222-1222. You should stop using the medication and consult a doctor if your condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then return within a few days, or if you experience rectal bleeding. Additionally, do not start using any other hydrocortisone product without first consulting a doctor.

FAQ

What is Hydrocortisone 1% used for?

Hydrocortisone 1% is an anti-itch cream that temporarily relieves itching associated with minor skin irritations, inflammation, and rashes, including conditions like eczema, insect bites, and poison ivy.

How should I use Hydrocortisone 1%?

For adults and children 2 years and older, apply to the affected area not more than 3 to 4 times daily. For children under 2 years, consult a doctor.

Are there any warnings for using this product?

Yes, avoid contact with 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 condition worsens?

Stop use and ask a doctor if your condition worsens, symptoms persist for more than 7 days, or if rectal bleeding occurs.

Is Hydrocortisone 1% safe to use during pregnancy?

The safety of Hydrocortisone during pregnancy has not been established, so consult a doctor before use.

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

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

What are the storage conditions for Hydrocortisone 1%?

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

Packaging Info

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

Packaging configurations for Signature Care Anti Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product contains hydrocortisone 1%, which is the #1 doctor-recommended active ingredient for anti-itch relief. It is formulated as a maximum strength cream designed to alleviate itching and promote healing of rashes, contributing to healthier skin. The product is packaged in a net weight of 1 ounce (28 grams) and is guaranteed for quality.

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, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis. 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 dosing 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, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first cleanse 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. 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 physician is also recommended 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 should be consulted in such cases.

When using this product, it is essential to avoid contact with the eyes. The product should not be used in excess of the directed dosage unless specifically instructed by a healthcare provider. Furthermore, it should not be administered directly into the rectum using fingers, mechanical devices, or applicators.

Warnings and Precautions

This product is intended for external use only. It is imperative that healthcare professionals advise patients against using this product in the genital area if they have a vaginal discharge; consultation with a doctor is recommended in such cases. Additionally, this product should not be used for the treatment of diaper rash without prior consultation with a healthcare provider.

When administering this product, it is crucial to avoid contact with the eyes. Patients should be instructed not to exceed the recommended dosage unless directed by a physician. Furthermore, the product should not be inserted directly into the rectum using fingers, mechanical devices, or applicators.

Patients should be advised to discontinue use and seek medical advice if their condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. It is also important to inform patients not to initiate the use of any other hydrocortisone product without consulting a healthcare professional. Immediate medical attention should be sought if rectal bleeding occurs.

In the event of accidental ingestion, patients should be instructed 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 intended 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, the 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 only to recur within a few days. It is also crucial to seek medical advice if rectal bleeding occurs.

In the event of accidental ingestion, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

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

Packaging configurations for Signature Care Anti Itch.
Details

Pediatric Use

For the treatment of itching associated with skin irritation, inflammation, and rashes, the medication is indicated for use in adults and children aged 2 years and older, with a recommended application of not more than 3 to 4 times daily to the affected area. For children under 2 years of age, consultation with a healthcare provider is advised prior to use.

In cases of external anal and genital itching, adults are instructed to cleanse the affected area with mild soap and warm water, followed by thorough rinsing. The area should be gently dried by patting or blotting with toilet tissue or a soft cloth before applying the medication, which should also be limited to 3 to 4 times daily. For children under 12 years of age, it is recommended to seek advice from a healthcare professional 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 safety of hydrocortisone during pregnancy has not been established. Pregnant patients or those planning to become pregnant should consult a healthcare professional before use. It is recommended that hydrocortisone 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 to fetal outcomes when prescribing hydrocortisone 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.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the drug insert text regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of information may necessitate careful clinical judgment and monitoring.

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, 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 compound in these areas.

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, patients should seek medical help 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 should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients must be instructed to stop using the product 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 advised not to begin the use of any other hydrocortisone product unless directed by a doctor.

If rectal bleeding occurs, patients should stop using the product and seek medical advice. While using this product, patients should avoid contact with their eyes to prevent irritation.

It is important to remind patients not to exceed the directed dosage unless specifically instructed to do so by a healthcare provider. Furthermore, patients should be cautioned 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

Patients aged 2 years and older, including adults, should apply the medication to the affected area no more than 3 to 4 times daily. For external anal and genital itching, adults are also advised to apply the medication to the affected area with the same frequency.

Clinicians should counsel patients to keep the product 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. Patients are advised to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, if symptoms clear up and then recur within a few days, or if rectal bleeding occurs. Additionally, patients should not start using any other hydrocortisone product without consulting a healthcare professional.

Drug Information (PDF)

This file contains official product information for Signature Care Anti Itch, 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 Anti Itch, 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.