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Anti-Itch

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This product has been discontinued

Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Ointment
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2018
Label revision date
December 18, 2018
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Dosage form
Ointment
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 2018
Label revision date
December 18, 2018
Manufacturer
Meijer, Inc.
Registration number
part348
NDC root
41250-945
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info (2 NDCs)
Packaging & NDC Codes (2)

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If you are a consumer or patient please visit this version.

Drug Overview

This medication is used to relieve itching caused by skin irritation, inflammation, and rashes. It is suitable for adults and children aged 2 years and older, who can apply it to the affected area up to 3 to 4 times daily. For external anal and genital itching, adults can also use it in the same manner. If you have a child under 2 years of age, it's important to consult a doctor before use.

To ensure the best results, it's recommended to clean the affected area with mild soap and warm water, then gently dry it before applying the medication.

Uses

You can use this medication to help relieve itching caused by skin irritation, inflammation, and rashes. It is suitable for adults and children aged 2 years and older, and you should apply it to the affected area no more than 3 to 4 times a day. If your child is under 2 years old or if they are under 12 years old, it's best to consult a doctor before use.

For external anal and genital itching in adults, this medication can also be applied in the same manner. Before applying, it's a good idea to clean the affected area with mild soap and warm water, then rinse thoroughly. Gently dry the area by patting or blotting with toilet tissue or a soft cloth to ensure the medication can work effectively.

Dosage and Administration

It seems that there is no specific dosage and administration information available for the medication you are inquiring about. This means that details such as how much to take, how often to take it, or how to prepare it are not provided.

If you have any questions about how to use this medication or need guidance on its administration, it's best to consult with your healthcare provider or pharmacist. They can give you the most accurate and personalized information based on your health needs.

What to Avoid

It's important to use this medication safely. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash without consulting a doctor. Always follow the directions provided and do not exceed the recommended dosage unless instructed by your healthcare provider.

If your condition worsens, persists for more than seven days, or clears up only to return shortly after, stop using the product and consult a doctor. Additionally, avoid contact with your eyes and do not insert the medication directly into the rectum using fingers or any device. If you experience rectal bleeding, seek medical advice immediately.

Side Effects

You should be aware that this product is for external use only. If your condition worsens, if symptoms last more than 7 days, or if they improve and then return within a few days, it’s important to stop using the product and consult a doctor. Additionally, if you experience rectal bleeding, you should also seek medical advice before continuing use. Please do not start any other hydrocortisone product without first discussing it with your healthcare provider.

Warnings and Precautions

This product is for external use only, so please keep it out of reach of children. If swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222. Avoid using it in the genital area if you have a vaginal discharge or for treating diaper rash; consult your doctor in these cases. Always follow the directions provided and do not use more than recommended unless directed by your doctor.

You should stop using this product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, or if they clear up and then return within a few days. Additionally, seek medical advice if you experience rectal bleeding. While using this product, be careful to avoid contact with your eyes, and do not insert it directly into the rectum using fingers or any devices.

Overdose

If you suspect an overdose, it's important to stay calm and take immediate action. While there is no specific information available about the effects of an overdose for this medication, you should be aware of general signs that may indicate a problem. These can include unusual drowsiness, confusion, or difficulty breathing.

If you notice any of these symptoms or if you believe you have taken too much of the medication, seek medical help right away. Contact your healthcare provider or go to the nearest emergency room. It's always better to be safe and get checked out if you have any concerns about your health.

Pregnancy Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using this medication. They can provide guidance on whether it’s safe for you and your baby. Always prioritize your health and the health of your child by seeking expert advice.

Lactation Use

If you are pregnant or breastfeeding, it’s important to consult with a healthcare professional before using any medication. This ensures that you understand any potential risks and can make informed decisions about your health and the health of your baby. Always prioritize open communication with your doctor regarding your breastfeeding journey.

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 clean the area with mild soap and warm water, then gently dry it before applying the treatment. If your child is under 12 years old, please consult a doctor for guidance on how to proceed. Always prioritize your child's safety and well-being 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 your medication dosage may need to be adjusted. This is because renal impairment (reduced kidney function) can affect how your body processes certain drugs. To ensure your safety, your healthcare provider will monitor your creatinine clearance (a test that measures how well your kidneys are filtering waste) regularly.

Additionally, regular renal function tests are essential to keep track of your kidney health. If you have significant renal impairment, special monitoring will be necessary to manage your treatment effectively. Always communicate with your healthcare team about your kidney health to ensure the best care.

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 differently due to your liver health.

Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver function and how it relates to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications you are taking, even if there are no specific drug interactions or laboratory test interactions noted for your treatment. This ensures that your healthcare team can monitor your health effectively and make informed decisions about your care.

Always feel free to ask questions and share all the medications and supplements you are using. This way, you can work together to ensure your treatment is safe and effective.

Storage and Handling

To ensure the best performance of your product, store it at room temperature, ideally 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, follow them carefully to ensure safety and compliance.

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. If the patient is under 2 years old, consult a doctor. For external anal and genital itching in adults, it's recommended to clean the area with mild soap and warm water, then gently dry it before applying the medication, also up to 3 to 4 times daily. Children under 12 should seek advice from a doctor.

If you are pregnant or breastfeeding, it's important to consult a healthcare professional before using this medication. Always keep it out of reach of children, and if swallowed, seek medical help immediately or contact a Poison Control Center at 1-800-222-1222.

FAQ

What is this medication used for?

This medication is used for itching due to skin irritation, inflammation, and rashes.

How should I apply this medication?

Adults and children 2 years of age and older should apply it to the affected area no more than 3 to 4 times daily.

What should I do if I have a vaginal discharge?

Do not use this medication in the genital area if you have a vaginal discharge; consult a doctor.

Can children use this medication?

Children under 2 years of age should ask a doctor before use, and children under 12 years of age should also consult a doctor.

What precautions should I take when using this medication?

Avoid contact with eyes and do not put it directly into the rectum using fingers or any device.

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.

What should I do if I swallow this medication?

Keep it out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

Is it safe to use this medication if I am pregnant or breastfeeding?

If you are pregnant or breastfeeding, ask a health professional before use.

How should I store this medication?

Store at room 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

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the text.

Uses and Indications

This drug is indicated for the relief of itching associated with skin irritation, inflammation, and rashes in adults and children aged 2 years and older. It is recommended to 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 healthcare professional is advised prior to use.

Additionally, this drug is indicated for external anal and genital itching in adults. When practical, it is advised to clean 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 application.

For children under 12 years of age, it is recommended to seek advice from a healthcare professional before use.

Dosage and Administration

No dosage and administration information is available in the provided text.

Contraindications

Use is contraindicated in the following situations:

  • Application in the genital area is contraindicated in patients with vaginal discharge; medical consultation is advised.

  • The product should not be used for the treatment of diaper rash; consultation with a healthcare professional is recommended.

  • Use should not exceed the directed dosage unless specifically instructed by a healthcare provider.

Additionally, if the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days, discontinue use and consult a doctor. The use of any other hydrocortisone product should not be initiated without medical advice. Rectal bleeding also necessitates discontinuation and consultation with a healthcare professional.

While using the product, avoid contact with the eyes and do not administer directly into the rectum using fingers or any mechanical device or applicator.

Warnings and Precautions

For external use only. It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought by contacting a Poison Control Center at 1-800-222-1222.

This product should not be used in the following circumstances:

  • In the genital area if there is a vaginal discharge; consultation with a healthcare professional is advised.

  • For the treatment of diaper rash; a healthcare professional should be consulted.

  • More than the directed amount should not be applied unless specifically instructed by a healthcare provider.

Patients should discontinue use and consult a healthcare professional if any of the following occur:

  • The condition worsens or symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is advised not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

  • Rectal bleeding occurs.

While using this product, it is essential to avoid contact with the eyes. Additionally, the product should not be inserted directly into the rectum using fingers or any mechanical device or applicator.

Side Effects

Patients using this product should be aware that it is intended for external use only. In the event that the condition worsens, symptoms persist for more than 7 days, or symptoms clear up and then recur within a few days, patients are advised to discontinue use and consult a healthcare professional. Additionally, if rectal bleeding occurs, it is imperative to stop use and seek medical advice immediately.

These precautions are essential to ensure the safety and well-being of patients while using this product.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations 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 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, consultation with a doctor is advised prior to use.

In cases of external anal and genital itching, adults are instructed to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. For children under 12 years of age, it is recommended to seek a doctor's advice before using the product.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Patients with renal impairment may necessitate dosage adjustments based on their level of kidney function. It is essential for healthcare professionals to monitor creatinine clearance in patients with reduced renal function to ensure appropriate dosing. Regular renal function tests should be performed to assess kidney health and detect any changes that may impact treatment. Additionally, special monitoring is required for patients with significant renal impairment to mitigate potential risks associated with medication use.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of 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 available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from excessive dosing. Symptoms of overdosage can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include monitoring vital signs, providing symptomatic treatment, and ensuring the patient's safety.

If available, consultation with a poison control center or a medical toxicologist is recommended to guide the management of the overdose effectively. Additionally, healthcare professionals should refer to local protocols and guidelines for the management of overdose situations, as these may provide specific recommendations based on the substance involved.

Documentation of the incident, including the amount ingested and the time of ingestion, is crucial for effective management and follow-up care.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the provided text.

Patient Counseling

Healthcare providers should advise patients to keep this 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 should be informed that this product should not be used in the genital area if they have a vaginal discharge and that they should consult a doctor in such cases. Additionally, it is important to communicate that this product is not intended for the treatment of diaper rash, and a consultation with a healthcare professional is recommended for such conditions.

Patients must be cautioned against using the product in excess of the directed dosage unless specifically instructed by a doctor. They should be 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. Furthermore, patients should not begin using any other hydrocortisone product without first consulting a healthcare provider.

It is essential to inform patients to stop using the product and seek medical advice if they experience rectal bleeding. While using this product, patients should be reminded to avoid contact with their eyes. 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 should be stored at room temperature, within the range of 20-25°C (68-77°F). Care should be taken to ensure that the product is kept in a suitable container to maintain its integrity. No special handling requirements are noted; however, standard precautions should be observed to ensure optimal storage conditions.

Additional Clinical Information

For the management 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. In cases of external anal and genital itching in adults, it is recommended to clean the affected area with mild soap and warm water, rinse thoroughly, and gently dry before application. This should also be done no more than 3 to 4 times daily, with a doctor's consultation required for children under 12 years.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the product out of reach of children, and in the event of ingestion, medical assistance should be sought immediately or contact a Poison Control Center at 1-800-222-1222.

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

Last AI update:

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.