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Anti-Itch

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Active ingredient
Hydrocortisone 10 mg/1 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 2010
Label revision date
January 10, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 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 2010
Label revision date
January 10, 2025
Manufacturer
Medline Industries, LP
Registration number
M017
NDC root
53329-091
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (4 NDCs)
Packaging & NDC Codes (4)

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

This medication provides temporary relief from itching caused by various minor skin irritations, including rashes from conditions like eczema, insect bites, and contact with plants such as poison ivy, poison oak, and poison sumac. It can also help soothe itching related to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes. Additionally, it is used for external genital, feminine, and anal itching.

While this product is effective for these purposes, it's important to use it under the advice and supervision of a doctor for any other uses.

Uses

You can use this product for temporary relief from itching caused by various minor skin irritations, including inflammation and rashes from conditions like eczema, insect bites, and reactions to poison ivy, poison oak, or poison sumac. It can also help with itching related to soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes.

Additionally, this product is suitable for relieving itching in external genital areas, as well as feminine and anal 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 are an adult or a child aged 2 years and older, you can apply this medication to the affected area up to 3 to 4 times a day. For children under 2 years old, it’s important not to use this product without first consulting a doctor.

If you are dealing with external anal itching, start by gently cleaning the affected area with mild soap and water, then rinse thoroughly. After that, make sure to dry the area carefully by patting or blotting it with toilet tissue or a soft cloth before applying the medication. If the person needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to be aware of certain situations where you should not use this product. First, do not use it for treating diaper rash or if you have a vaginal discharge. Additionally, make sure to follow the recommended daily dosage; do not exceed it unless your doctor advises you to do so. Avoid inserting this product into the rectum using your fingers or any device. If your condition worsens, or if symptoms last more than 7 days or return shortly after improvement, stop using the product and consult your doctor before trying any other hydrocortisone (a type of steroid used to reduce inflammation) products.

By following these guidelines, you can help ensure your safety and the effectiveness of your treatment.

Side Effects

You should use this product only on the skin and avoid getting it in your eyes. It is not intended for treating diaper rash or vaginal discharge. If your condition worsens, symptoms last more than 7 days, or if they improve and then return shortly after, stop using the product and consult your doctor before trying any other hydrocortisone products.

Be sure to follow the recommended dosage and do not exceed it unless your doctor advises you to. If you experience any bleeding, seek medical attention right away. Additionally, do not use your fingers or any devices to apply this product rectally.

Warnings and Precautions

This product is for external use only, so please avoid contact with your eyes. It is important not to use it for treating diaper rash or if you have a vaginal discharge. If your condition worsens, or if symptoms last more than 7 days or improve and then return within a few days, stop using the product and consult your doctor before trying any other hydrocortisone products. Always follow the recommended dosage and do not exceed it unless directed by your doctor. If you experience any bleeding, seek medical attention promptly.

In case of accidental swallowing, get emergency help or contact a Poison Control Center immediately. Remember, if your symptoms worsen or persist beyond 7 days, stop using the product and reach out to your healthcare provider for guidance.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to seek medical help immediately. You can do this by contacting a Poison Control Center or going to the nearest emergency room.

Signs of an overdose can vary, but they may include unusual symptoms that are not typical for the medication. Always err on the side of caution and get help if you suspect an overdose has occurred. Remember, acting quickly can make a significant difference in the outcome.

Pregnancy Use

If you are pregnant or planning to become pregnant, it is important to consult your doctor before using this product. You should not use it during pregnancy unless your doctor specifically directs you to do so. Always prioritize your health and the health of your baby by seeking professional guidance.

Lactation Use

If you are breastfeeding or planning to breastfeed, it's important to talk to your doctor before using this product. There is a possibility that it can be passed into your breast milk, and the effects on your nursing infant have not been thoroughly studied. Therefore, exercising caution is recommended to ensure the safety and well-being of both you and your baby.

Pediatric Use

When using this medication for children, it's important to follow specific guidelines. For children aged 2 years and older, you can apply it to the affected area up to 3 to 4 times a day. However, if your child is under 2 years old, you should not use this medication without first consulting a doctor. Additionally, if your child is under 12 years old, it's best to check with a doctor before use to ensure safety and proper dosage. Always prioritize your child's health by seeking 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 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 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).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that you receive the safest and most effective care.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, always ensure that your healthcare provider is aware of all the medications you are using, as this helps them provide the best care tailored to your needs.

By discussing your full medical history and any other treatments, you can help prevent potential issues and ensure your safety.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at a controlled room temperature between 68° and 77° F (20° and 25° C). It's important to only use the product if the package is intact, as this helps maintain its quality and safety. Always handle the product with care to avoid any damage or contamination.

Additional Information

You should apply this product to the affected area no more than 3 to 4 times a day if you are an adult or a child aged 2 years and older. If you are dealing with external anal itching, it's best to first cleanse the area with mild soap and water, rinse thoroughly, and then gently dry it by patting or blotting with toilet tissue or a soft cloth before applying the product.

FAQ

What is this product used for?

This product provides temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to conditions like eczema, insect bites, and poison ivy.

Who can use this product?

Adults and children 2 years of age and older can use this product. Children under 2 years should consult a doctor.

How often can I apply this product?

You can apply it to the affected area not more than 3 to 4 times daily.

Are there any contraindications for this product?

Do not use this product for the treatment of diaper rash or if you have a vaginal discharge.

What should I do if my condition worsens?

If your condition worsens or symptoms persist for more than 7 days, stop using the product and consult a doctor.

Can I use this product during pregnancy?

Do not use this product in pregnancy unless directed by a doctor. Consult your doctor if you are pregnant or planning to become pregnant.

Is this product safe for nursing mothers?

Nursing mothers should consult a doctor before using this product, as there is a potential for excretion in breast milk.

What should I do if I accidentally swallow this product?

If swallowed, get medical help or contact a Poison Control Center right away.

What precautions should I take when using this product?

Avoid contact with eyes and do not put this product into the rectum using fingers or any mechanical device.

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

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet, which is debossed with "A" on one side and "B" on the other. Each tablet contains 500 mg of the active ingredient. The formulation includes the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, iron oxide red, and iron oxide yellow.

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, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis, and scrapes. Additionally, it is indicated for external genital, feminine, and anal itching.

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

Dosage and Administration

For adults and children aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. For children under 2 years of age, the product is not recommended; consultation with a healthcare professional is advised.

In cases of external anal itching, it is recommended that adults first cleanse the affected area with mild soap and water, followed by thorough rinsing. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth prior to the application of the product. For children under 12 years of age, consultation with a healthcare professional is also recommended before use.

Contraindications

The product is contraindicated for the treatment of diaper rash and in patients presenting with vaginal discharge.

Additionally, the recommended daily dosage should not be exceeded unless directed by a healthcare professional. The product must not be administered rectally using fingers or any mechanical device or applicator. If the condition worsens, or if symptoms persist for more than 7 days or recur within a few days after resolution, discontinue use and consult a healthcare professional before initiating any other hydrocortisone product.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury.

The product is not indicated for the treatment of diaper rash. Additionally, it should not be used if there is a vaginal discharge present. In the event that the condition worsens, or if symptoms persist beyond 7 days, or if symptoms resolve and then recur within a few days, the use of this product should be discontinued. Consultation with a healthcare professional is advised before initiating any other hydrocortisone product.

Healthcare professionals should ensure that patients do not exceed the recommended daily dosage unless specifically directed by a physician. In cases of bleeding, prompt consultation with a physician is necessary. It is also crucial to instruct patients not to insert this product into the rectum using fingers or any mechanical device or applicator.

Emergency medical assistance should be sought immediately if the product is swallowed, or if contact is made with a Poison Control Center.

Patients should be advised to stop using the product and contact their healthcare provider if the condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then reappear within a few days.

Side Effects

Patients using this product should be aware that it is intended for external use only and must avoid contact with the eyes. Serious adverse reactions may occur if the product is misused or applied improperly.

Participants are advised not to use this product for the treatment of diaper rash or if they have a vaginal discharge. If the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, patients should discontinue use and consult a doctor before starting any other hydrocortisone product.

It is crucial for patients to adhere to the recommended daily dosage and not exceed it unless directed by a physician. In the event of bleeding, patients should seek medical attention promptly. Additionally, this product should not be inserted into the rectum using fingers or any mechanical device or applicator, as this may lead to further complications.

Drug Interactions

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

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 no more than 3 to 4 times daily. For children under 2 years of age, the medication is not recommended, and a healthcare professional should be consulted prior to use. Additionally, for children under 12 years of age, it is advised to consult a doctor before administration.

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

Pregnant patients should not use this product unless directed by a healthcare professional. It is essential for women who are pregnant or planning to become pregnant to consult their doctor prior to using this product. The potential risks and benefits must be carefully evaluated in the context of individual circumstances.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and the effects on a nursing infant are not well studied; therefore, caution is advised.

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 in these patients to ensure safety and therapeutic effectiveness.

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.

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 procedures 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 address any complications that may arise from an overdosage scenario.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the insert.

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.

Patients should be informed that this product is not intended for the treatment of diaper rash and should not be used if they have a vaginal discharge. It is important to counsel patients to discontinue use if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. In such cases, patients should be instructed not to start any other hydrocortisone product without consulting a doctor.

Providers should emphasize the importance of adhering to the recommended daily dosage and advise patients not to exceed this dosage unless directed by a healthcare professional. Additionally, patients should be made aware that in the case of bleeding, they should consult a physician promptly.

Finally, it is crucial to inform patients that this product should not be inserted into the rectum using fingers, mechanical devices, or applicators.

Storage and Handling

The product is supplied in a configuration that ensures integrity and safety. It must be stored at a controlled room temperature, specifically between 68° and 77° F (20° and 25° C). It is imperative to use the product only if the package is intact, as this ensures the quality and efficacy of the contents. Proper handling and storage conditions are essential to maintain the product's stability and effectiveness.

Additional Clinical Information

For patients aged 2 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. In cases of external anal itching in adults, it is recommended to cleanse the affected area with mild soap and 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 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.