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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 2021
Label revision date
September 17, 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 2021
Label revision date
September 17, 2024
Manufacturer
Meijer, Inc.
Registration number
M017
NDC root
79481-0319
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% is a maximum strength anti-itch cream designed to provide temporary relief from itching associated with minor skin irritations, inflammation, and rashes. It is effective for various conditions, including eczema, psoriasis, poison ivy, insect bites, and reactions to detergents, jewelry, cosmetics, and soaps. Additionally, it can help soothe external anal and genital itching.

This cream works by reducing inflammation and redness, offering fast relief from discomfort. It is paraben-free, making it a suitable option for those looking for a gentle yet powerful solution to alleviate skin irritation. Always consult with a doctor for any other uses beyond the typical applications.

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 if you are an adult or a child 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 itching in the anal and genital areas, adults should first clean the area with mild soap and warm water, making sure to rinse thoroughly. After cleaning, gently dry the area by patting it 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 needing treatment is under 12 years old, please consult a doctor for guidance.

What to Avoid

It's important to use this medication safely. You should not apply it in the genital area if you have a vaginal discharge or use it for diaper rash; in these cases, please consult your doctor. Additionally, avoid contact with your eyes and do not exceed the recommended dosage unless directed by your healthcare provider. Never insert the medication directly into the rectum using your fingers or any device.

Remember, using this medication improperly can lead to issues such as dependence (a condition where your body becomes reliant on a substance) or misuse. Always follow your doctor's advice to ensure your safety and well-being.

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 notice that your condition worsens, symptoms last longer than 7 days, or if you experience rectal bleeding, stop using the product and consult a doctor. Additionally, do not use this product in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a healthcare professional.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately 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, 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 are not typical for you. If you notice any concerning changes in behavior or health, don’t hesitate to reach out for help. Remember, acting quickly can make a significant difference in ensuring safety and health.

Pregnancy Use

When it comes to using hydrocortisone cream during pregnancy, there is no specific information available about its safety, dosage adjustments, or any special precautions you should take. This means that if you are pregnant or planning to become pregnant, it’s important to consult with your healthcare provider before using this cream. They can help you weigh the potential benefits and risks based on your individual situation. Always prioritize open communication with your doctor to ensure the best care for you and your baby.

Lactation Use

If you are breastfeeding, it's important to consult your doctor before using this product. There is a possibility that it may be excreted in breast milk, which means it could potentially affect your nursing infant. Therefore, exercising caution while using this product during breastfeeding is strongly advised. Always prioritize your health and your baby's well-being by discussing any concerns with your healthcare provider.

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 if they are 2 years old or older. However, if your child is under 2 years of age, 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. Children under 12 years of age should also consult a doctor 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 in the drug insert. This means that healthcare providers may not have detailed guidelines tailored for elderly patients. If you or a loved one is an older adult considering this medication, it’s important to discuss any concerns with your doctor. They can help determine the best approach based on individual health needs and any other medications being taken.

Always remember that older adults may have different responses to medications, so close monitoring for any side effects or changes in health is essential. Your healthcare provider can guide you on the appropriate dosage and any necessary precautions to ensure safety and effectiveness.

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 you understand how to manage your treatment effectively.

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 the integrity and effectiveness of the device.

When handling the product, be sure to do so with clean hands and in a clean environment to avoid contamination. If you have any specific disposal instructions, please follow them carefully to ensure safety and compliance.

Additional Information

You can use this medication topically to relieve itching caused by skin irritation, inflammation, and rashes. For both adults and children aged 2 years and older, apply it to the affected area no more than 3 to 4 times a day. If you're dealing with external anal and genital itching, adults should also apply it to the affected area up to 3 to 4 times daily. Always follow the recommended application frequency for the best results.

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, psoriasis, and insect bites.

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 external anal and genital itching, clean the area first, then apply the cream.

Are there any contraindications for using this cream?

Do not use HYDROCORTISONE 1% in the genital area if you have a vaginal discharge or for the treatment of diaper rash without consulting a doctor.

What should I do if my condition worsens?

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 it safe to use HYDROCORTISONE 1% during pregnancy?

The product insert does not provide specific information regarding the use of hydrocortisone cream during pregnancy, so consult your doctor for advice.

Can nursing mothers use this product?

Nursing mothers should consult a doctor before using HYDROCORTISONE 1%, as there is a potential for the drug to be excreted in breast milk.

What are the side effects of HYDROCORTISONE 1%?

Common side effects may include irritation at the application site. If you experience severe reactions, seek medical help immediately.

How should I store HYDROCORTISONE 1%?

Store the cream at a temperature between 20-25°C (68-77°F).

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

Hydrocortisone 1% with soothing aloe is formulated to provide relief from itch, irritation, and rashes associated with various dermatological conditions. This topical preparation is effective in addressing inflammation and redness caused by insect bites, poison ivy, eczema, and psoriasis. The active ingredient delivers powerful medicinal properties for fast relief. The product is presented in a cream dosage form, with 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, sumac, insect bites, detergents, jewelry, cosmetics, soaps, and 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; consultation with a healthcare professional is advised.

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

Contraindications

Use is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. It is also contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted 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 physician. Additionally, direct application into the rectum using fingers, mechanical devices, or applicators is contraindicated.

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 in such cases. Additionally, it should not be used for the treatment of diaper rash without prior consultation with a doctor.

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. It is also important to refrain from inserting the product directly into the rectum using fingers or any mechanical device or applicator.

Users must 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. It is crucial 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, it is essential to obtain 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, 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.

To ensure safety, 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

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 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 use the medication for the relief of itching associated with skin irritation, inflammation, and rashes. The recommended application is to the affected area not 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 doctor is advised.

In cases of external anal and genital itching, the same application frequency applies for adults. It is recommended that the affected area be cleaned with mild soap and warm water, rinsed thoroughly, and gently dried by patting or blotting with toilet tissue or a soft cloth prior to application. For pediatric patients under 12 years of age, it is advised to consult a doctor before use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients. Therefore, healthcare providers should exercise caution when prescribing this medication to elderly patients. It is advisable to closely monitor this population for any potential adverse effects or changes in drug efficacy, given the physiological changes associated with aging that may affect drug metabolism and response. Additionally, consideration should be given to the possibility of altered pharmacokinetics and pharmacodynamics in geriatric patients, which may necessitate dosage adjustments or increased monitoring.

Pregnancy

The safety of hydrocortisone cream during pregnancy has not been established, as the prescribing information does not provide specific data regarding its use in this population. Consequently, healthcare professionals should exercise caution when recommending this medication to pregnant patients. There are no documented safety concerns, dosage modifications, or special precautions outlined for the use of hydrocortisone cream in pregnant women. Given the lack of information, it is advisable for women of childbearing potential to discuss the potential risks and benefits with their healthcare provider before using this medication during pregnancy.

Lactation

Lactating mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when using this product while breastfeeding.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

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. 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 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 understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are available in the provided data.

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 help 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 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 cautioned against 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 advised to avoid contact with the eyes. It is crucial to inform patients not to exceed the recommended dosage unless directed by a doctor. Lastly, patients should be instructed not to insert 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 for the treatment of itching associated with skin irritation, inflammation, and rashes in patients aged 2 years and older. It should be applied to the affected area no more than 3 to 4 times daily. For external anal and genital itching in adults, the same frequency of application is recommended.

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.

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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.