Symptom checker
Select audience type

Switch between content for healthcare professionals (PRO) and general audience (GEN).

ADD CONDITION

items per page

Anti Itch

Last content change checked dailysee data sync status

Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Gel
Route
Rectal
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
April 20, 2024
Drug Information (PDF)
Prescribing information, PDF file
Active ingredient
Hydrocortisone 1 g/100 g
Other brand names
Drug class
Corticosteroid
Dosage form
Gel
Route
Rectal
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
April 20, 2024
Manufacturer
Neilmed Pharmaceuticals Inc.
Registration number
M017
NDC root
13709-326
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

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

Drug Overview

Hydrocortisone 1% cool relief gel with aloe is a topical gel designed to provide relief from itching caused by skin irritation, inflammation, and rashes. This formulation contains 1% hydrocortisone, which helps soothe discomfort and reduce inflammation on the skin. It is suitable for use by adults and children aged 2 years and older, making it a helpful option for managing various skin irritations.

When using this gel, you can apply it to the affected area up to 3 to 4 times daily, ensuring that you follow any specific guidance if you are caring for a child under 2 years old or if you are pregnant or breastfeeding.

Uses

You can use this medication to relieve itching caused by skin irritation, inflammation, and rashes for both adults and children aged 2 years and older. Simply apply it to the affected area up to 3 to 4 times a day. If you're dealing with external anal or genital itching as an adult, it's best to clean the area with mild soap and warm water, rinse thoroughly, and gently dry it before applying the medication.

If your child is under 2 years old, or if your child is under 12 years old, it's important to consult a doctor before use. Additionally, if you are pregnant or breastfeeding, make sure to talk to a healthcare professional before using this product to ensure it's safe for you.

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 the medication.

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 or blotting it with toilet tissue or a soft cloth. You can then apply the medication to the affected area, again not exceeding 3 to 4 times daily.

What to Avoid

It's important to use this product safely to avoid potential issues. You should not use it in the genital area if you have a vaginal discharge or for treating diaper rash—please consult your doctor in these cases. Additionally, avoid inserting the product directly into the rectum using your fingers or any device, and do not exceed the recommended dosage unless directed by your doctor.

While using this product, be careful to keep it away from your eyes to prevent irritation. Always prioritize your health and consult a healthcare professional if you have any concerns.

Side Effects

You should only use this product externally and avoid applying it in the genital area if you have a vaginal discharge. It's also important not to use it for treating diaper rash without consulting a doctor.

If your condition worsens, if symptoms last more than 7 days, or if they clear up and then return within a few days, stop using the product and talk to your doctor. Additionally, seek medical advice if you experience rectal bleeding.

Warnings and Precautions

This product is intended for external use only. If you have a vaginal discharge, avoid using it in the genital area and consult your doctor. It is also not suitable for treating diaper rash, so please speak with a healthcare professional if you need treatment for that.

You should stop using this product and contact your doctor if your condition worsens, if symptoms last longer than 7 days, or if they improve and then return within a few days. Additionally, seek medical attention if you experience rectal bleeding. If the product is accidentally swallowed, get medical help or reach out to a Poison Control Center immediately.

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 signs of overdose for this medication, general symptoms can include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these signs, or if you are unsure, seek medical help right away.

In case of an overdose, contact your local emergency services or go to the nearest hospital. It's always better to be safe and get checked by a healthcare professional if you have any concerns about your health. Remember, timely action can make a significant difference.

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 under 2 years old, it's important to consult a doctor before using this medication. For children aged 2 years and older, you can apply the medication to the affected area up to 3 to 4 times a day. However, if your child is under 12 years old and is experiencing external anal or genital itching, you should also seek advice from a doctor before proceeding. Always prioritize your child's safety and well-being by following these guidelines.

Geriatric Use

While there is no specific information available about the use of this medication in older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s always wise to discuss any medications with a healthcare provider, especially since older individuals may have different health needs and responses to treatments.

Since there are no dosage adjustments or special precautions mentioned for elderly patients, your healthcare provider can help determine the best approach based on individual health conditions and any other medications being taken. Always prioritize open communication with your doctor to ensure safe and effective use of any medication.

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 is safe and effective for your specific condition. They can help you understand any necessary precautions or adjustments based on your kidney health.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

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 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 helps to avoid any potential issues and ensures that you receive the best possible treatment tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it in a cool, dry place where the temperature does not exceed 30°C (86°F). It's important to protect the product from freezing, as extreme cold can damage it. Additionally, keep the original carton, as it contains important information that you may need later.

When handling the product, always do so with care to maintain its integrity. Following these storage and handling guidelines will help ensure your product remains safe and effective for use.

Additional Information

No further information is available.

FAQ

What is Hydrocortisone 1% cool relief gel used for?

Hydrocortisone 1% cool relief gel is used for relief of itching associated with skin irritation, inflammation, and rashes.

How should I apply Hydrocortisone 1% gel?

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

Can I use this gel if I am pregnant or breastfeeding?

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

Are there any specific instructions for external anal and genital itching?

Yes, clean the affected area with mild soap and warm water, gently dry it, and apply the gel not more than 3 to 4 times daily. For children under 12 years, consult a doctor.

What should I avoid while using this product?

Avoid contact with eyes and do not use more than directed unless told to do so by a doctor.

When should I stop using Hydrocortisone 1% gel?

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

Can I use this gel for diaper rash?

No, do not use for the treatment of diaper rash; consult a doctor instead.

What should I do if I accidentally swallow the gel?

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

How should I store Hydrocortisone 1% gel?

Store at a temperature not to exceed 30°C (86°F) and protect from freezing.

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% cool relief gel is a topical formulation designed to provide localized relief. The gel contains 1% hydrocortisone, a corticosteroid known for its anti-inflammatory properties. It is formulated with aloe, which is included for its soothing and moisturizing effects. The product is presented in a gel dosage form, facilitating easy application to affected areas.

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 should be applied to the affected area no more than 3 to 4 times daily.

For external anal and genital itching in adults, it is recommended to clean the affected area with mild soap and warm water, rinsing thoroughly. The area should then be gently dried by patting or blotting with toilet tissue or a soft cloth before application. This drug should also be applied 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. Additionally, for children under 12 years of age, it is recommended to seek a doctor's advice before administration.

In pregnant or breastfeeding individuals, it is essential to consult a health professional before use. No nonteratogenic effects have been mentioned.

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, it is advised to consult a physician prior to use.

In cases of external anal and genital itching in adults, it is recommended to first 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. Following this preparation, the medication should be applied to the affected area no more than 3 to 4 times daily.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to the genital area in the presence of vaginal discharge; medical consultation is advised. Additionally, it is contraindicated for the treatment of diaper rash, and a healthcare professional should be consulted in such cases.

Direct application into the rectum using fingers, mechanical devices, or applicators is prohibited. Furthermore, the product should not be used in excess of the recommended dosage unless directed by a physician.

Care should be taken to avoid contact with the eyes during use.

Warnings and Precautions

This product is intended for external use only. It is contraindicated for application in the genital area, particularly in the presence of vaginal discharge; healthcare professionals should advise patients to consult a doctor in such cases. Additionally, this product should not be utilized for the treatment of diaper rash without prior consultation with a healthcare provider.

Patients are advised to discontinue use and seek medical advice if any of the following occur: the condition worsens, symptoms persist for more than 7 days, or if symptoms resolve only to recur within a few days. It is important to refrain from using any other hydrocortisone products unless directed by a healthcare professional. Furthermore, if rectal bleeding is experienced, immediate medical consultation is necessary.

In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center promptly.

Side Effects

Patients should be aware that the product 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.

Patients are instructed 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. Furthermore, if rectal bleeding occurs, patients should stop using the product and consult a doctor immediately. It is important for patients not to begin the use of any other hydrocortisone product without first consulting a healthcare provider.

Drug Interactions

No specific drug interactions have been identified in the available data. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on the current information.

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 under 2 years of age should consult a doctor before use. For children aged 2 years and older, the recommended application is to the affected area no more than 3 to 4 times daily. Additionally, for external anal and genital itching, it is advised that children under 12 years of age seek medical advice prior to use.

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 adverse effects or changes in therapeutic response, 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 considered, 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 no specific data available regarding the excretion of this medication in 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 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 based on clinical judgment.

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, as the lack of detailed overdosage data necessitates a vigilant approach. Symptoms of overdose 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.

Additionally, contacting a poison control center or consulting with a medical toxicologist may be beneficial for guidance on specific management strategies tailored to the situation.

Overall, while specific overdosage information is not available, the emphasis remains on prompt recognition and appropriate management of any adverse effects that may occur.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified. Additionally, there are no detailed findings related to nonclinical toxicology or animal pharmacology and toxicology available.

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. In the event of accidental ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

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 should be instructed 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. They should also be advised not to begin the use of any other hydrocortisone product without first consulting a healthcare provider.

It is crucial to inform patients to stop using the product and seek medical advice if they experience rectal bleeding. While using this product, patients should be cautioned to avoid contact with their eyes.

Healthcare providers should emphasize that patients must not 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 a carton that contains important information for the user. It is essential to store the product at a temperature not to exceed 30°C (86°F) to maintain its efficacy. Additionally, the product must be protected from freezing to ensure its integrity. Care should be taken to keep the carton for reference to the critical information it contains.

Additional Clinical Information

No further data are available.

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.