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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 2024
Label revision date
January 8, 2025
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 2024
Label revision date
January 8, 2025
Manufacturer
Safeway
Registration number
M017
NDC root
21130-433
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

Signature SELECT™ ANTI-ITCH CREAM is a topical cream that contains hydrocortisone 1%, which is a maximum strength medication designed to provide temporary relief from itching. This cream is effective for minor skin irritations, inflammation, and rashes caused by various conditions, including eczema, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

In addition to these uses, it can also help relieve external anal and genital itching. If you have any other uses in mind, it's important to consult with a doctor for advice and supervision.

Uses

This product is designed to help you temporarily relieve itching caused by various minor skin irritations, inflammation, and rashes. You can use it for conditions like eczema, insect bites, and reactions to poison ivy, oak, or sumac. It’s also effective against itching from soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

In addition, this product can provide temporary relief for external anal and genital itching. If you have other uses in mind, it's best to consult with your doctor for advice 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 itching around the anal and genital areas in adults, start by gently cleansing the area with mild soap and warm water, then rinse thoroughly. After that, 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 check with a doctor before using the medication.

What to Avoid

You should avoid using this product in the genital area if you have a vaginal discharge or for treating diaper rash—please consult a doctor in these cases. If you experience rectal bleeding, notice that your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and seek medical advice.

While using this product, be careful to keep it away from your eyes, and do not exceed the recommended dosage unless directed by a doctor. Additionally, do not insert the product directly into the rectum using your fingers or any device.

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 rectal bleeding, if your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

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. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

Warnings and Precautions

This product is for external use only, so please avoid applying it to any internal areas. If you have a vaginal discharge, do not use it in the genital area and consult your doctor. Additionally, it is not intended for treating diaper rash; please speak with a healthcare professional for appropriate options.

You should stop using this product and contact your doctor if you experience rectal bleeding, if your condition worsens, or if your symptoms last longer than 7 days. If your symptoms improve and then return within a few days, do not use this or any other hydrocortisone product without consulting your doctor first.

In case of accidental swallowing, seek emergency medical help immediately or contact a Poison Control Center 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 if you notice unusual symptoms or feel unwell after taking the medication, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

It is important to avoid using this product if you are pregnant. If you are currently pregnant or planning to become pregnant, you should consult your doctor before using it. Your healthcare provider can help you understand the potential risks and make informed decisions about your health and the health of your baby.

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 this treatment.

For external anal and genital itching, you should also consult a doctor if your child is under 12 years of age. 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 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 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 great to know that there are no reported interactions between this medication and other drugs or laboratory tests. However, it's still very important to discuss all medications you are taking, including over-the-counter drugs and supplements, with your healthcare provider. This ensures that your treatment is safe and effective.

Always keep your healthcare provider informed about any changes in your health or new medications you start. Open communication helps prevent any potential issues and supports your overall well-being.

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

For treating itching caused by 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 the patient is under 2 years old, you should consult a doctor before use.

For external anal and genital itching in adults, it's recommended to first cleanse the area with mild soap and warm water, then gently dry it before applying the medication. Again, you can apply it up to 3 to 4 times daily. If the patient is under 12 years old, please consult a doctor for guidance.

FAQ

What is Signature SELECT™ ANTI-ITCH CREAM used for?

It temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

Who can use Signature SELECT™ ANTI-ITCH CREAM?

Adults and children 2 years of age and older can use it, but children under 2 years should consult a doctor.

How should I apply this cream?

Apply to the affected area not more than 3 to 4 times daily, and cleanse the area with mild soap and warm water before application for external anal and genital itching.

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.

What should I do if I experience rectal bleeding?

Stop use and ask a doctor if rectal bleeding occurs or if symptoms worsen or persist for more than 7 days.

Can I use this cream if I am pregnant?

Do not use this product during pregnancy; consult a doctor if you are pregnant or planning to become pregnant.

What should I do if the cream is swallowed?

Get medical help or contact a Poison Control Center immediately if swallowed.

Is there any specific information for nursing mothers?

There are no specific warnings or recommendations regarding the use of this product by nursing mothers.

What is the net weight of Signature SELECT™ ANTI-ITCH CREAM?

The net weight is 1 OZ (28 g).

Packaging Info

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

Packaging configurations for Anti Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

Signature SELECT™ Anti-Itch Cream contains hydrocortisone 1%, representing the maximum strength formulation available. This topical preparation is designed for the relief of itching associated with minor skin irritations. The product is packaged in a net weight of 1 ounce (28 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, insect bites, poison ivy, oak, or sumac, as well as reactions to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, and psoriasis.

Additionally, this drug 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.

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; consultation with a healthcare professional is advised.

In cases of external anal and genital itching in adults, it is advisable 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 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, it is recommended to consult a healthcare professional before use.

Contraindications

Use of this product is contraindicated in the following situations:

  • Application in the genital area is not recommended for patients with vaginal discharge; consultation with a healthcare professional is advised.

  • The product should not be used for the treatment of diaper rash without prior consultation with a healthcare professional.

Patients should discontinue use and seek medical advice if rectal bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, this product should not be used in conjunction with any other hydrocortisone product unless directed by a healthcare professional.

While using this product, it is essential to avoid contact with the eyes, adhere to the recommended dosage, and refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. This product is not intended for use in the genital area if there is a vaginal discharge; in such cases, consultation with a healthcare professional is advised. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a doctor.

Healthcare professionals should instruct patients to discontinue use and seek medical advice if rectal bleeding occurs. Furthermore, if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should refrain from using this or any other hydrocortisone product unless directed by a healthcare provider.

In the event of accidental ingestion, it is imperative to seek emergency medical assistance immediately or contact a Poison Control Center 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. The product should not be administered directly into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical advice if rectal bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days. If symptoms clear up and then recur within a few days, patients should refrain from using this or any other hydrocortisone product without consulting a doctor.

This product should be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Drug Interactions

There are no reported drug interactions associated with the use of this medication. Additionally, no interactions with laboratory tests have been identified. Therefore, no specific dosage adjustments or monitoring recommendations are necessary based on drug interactions.

Packaging & NDC

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

Packaging configurations for Anti Itch.
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, the use of this medication is not recommended; consultation with a doctor is advised.

In cases of external anal and genital itching, it is recommended 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

The use of this product is contraindicated in pregnant patients. Women who are pregnant or planning to become pregnant should consult a healthcare professional prior to using this product. It is essential to evaluate the potential risks and benefits in such cases to ensure the safety of both the patient and the developing fetus.

Lactation

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

Renal Impairment

Patients with renal impairment have not been specifically addressed in the 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 absence of detailed guidance necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to 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 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. It is recommended that healthcare providers assess the patient's condition and consider the necessity of supportive care or specific treatment protocols based on the severity of symptoms presented.

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. 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 the 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 product 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 stop using the product and consult a doctor if rectal bleeding occurs. Patients should also be advised to discontinue use and seek medical advice 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 crucial to inform patients not to use this or any other hydrocortisone product without first consulting a doctor.

While using the product, patients should be cautioned to avoid contact with their eyes. Providers should also remind patients not to exceed the recommended dosage unless directed by a doctor. Furthermore, 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 exposure to extreme temperatures, which may compromise the product's quality.

Additional Clinical Information

For the treatment of itching associated with skin irritation, inflammation, and rashes, 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, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching in adults, it is recommended to cleanse the affected 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, the medication should be applied to the affected area no more than 3 to 4 times daily. For children under 12 years of age, a doctor's consultation is also recommended.

Drug Information (PDF)

This file contains official product information for 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 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.