Symptom checker
Select audience type

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

ADD CONDITION

items per page

Skin a Cool Hydrocortisone Anti-Itch

Last content change checked dailysee data sync status

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 2021
Label revision date
November 10, 2023
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 2021
Label revision date
November 10, 2023
Manufacturer
Ana-Cool, LLC
Registration number
M017
NDC root
70288-173
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

This medication is designed to provide temporary relief from skin itching. It can help soothe discomfort associated with minor skin irritations and rashes. If you have any other uses in mind, it's important to consult with a doctor for guidance and supervision.

Uses

If you're dealing with skin itching, this product can provide temporary relief. It's particularly effective for soothing itching caused by minor skin irritations and rashes. However, for any other uses, it's important to consult with your doctor for guidance and supervision.

Dosage and Administration

To use this medication effectively, apply it 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, it’s best to start by gently cleaning the area with mild soap and warm water. Make sure to rinse it thoroughly or pat it dry with a suitable cleansing pad before applying the medication.

If your child is under 2 years old, do not use this medication without first consulting a doctor. Additionally, if your child is under 12 years of age, it’s important to check with a doctor before use to ensure safety and proper guidance.

What to Avoid

It's important to use this product safely and effectively. You should not use it for treating diaper rash; if you have concerns about diaper rash, please consult your doctor. Additionally, make sure to follow the recommended daily dosage and avoid exceeding it unless your doctor advises otherwise.

For your safety, do not insert this product into the rectum using your fingers or any mechanical device or applicator. Following these guidelines will help ensure that you use the product correctly and minimize any potential risks.

Side Effects

When using this product, it's important to be aware of some key precautions. This medication is for external use only, and you should avoid contact with your eyes. If you experience any bleeding, or if your condition worsens or does not improve after 7 days, you should consult a doctor. Additionally, do not use this product for diaper rash, and refrain from using it in the rectum with fingers or any devices.

Keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center immediately. Always follow the recommended dosage and consult a doctor before using any other hydrocortisone products.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rashes without consulting a doctor. When using this product, be careful not to get it in your eyes, and do not exceed the recommended daily dosage unless your doctor advises you to do so. If you experience any bleeding, seek medical attention immediately. Additionally, do not insert this product into the rectum using fingers or any devices.

If your condition worsens, or if symptoms last longer than 7 days or return after clearing up, stop using the product and consult your doctor. It's important to keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Center right away.

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. Acting quickly can make a significant difference in the outcome.

Signs of an overdose can vary, but they may include unusual drowsiness, confusion, or difficulty breathing. If you notice any of these symptoms, don’t hesitate to get help right away. Remember, it’s always better to be safe and get checked by a medical professional if you suspect an overdose.

Pregnancy Use

If you are pregnant or planning to become pregnant, it’s important to consult your doctor before using this medication. This is especially crucial if you have children under 2 years of age, as you should cleanse the affected area when practical. For adults and children under 12 years, seeking medical advice is recommended to ensure safety.

Additionally, make sure to store the medication properly at a temperature between 20-25°C (68-77°F) to maintain its effectiveness. Always prioritize your health and the health of your child by discussing any concerns with your healthcare provider.

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 may pass into your breast milk, and the effects on your nursing infant are not fully understood. Taking this precaution can help ensure the safety and well-being of both you and your baby.

Pediatric Use

If you have a child 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 it to the affected area, but make sure to do so no more than 3 to 4 times a day. Additionally, if your child is under 12 years old, it's best to check with a doctor before using this product to ensure it's safe and appropriate for them. Always prioritize your child's health by seeking professional advice when needed.

Geriatric Use

While there is no specific information about how this medication should be used by older adults, it’s important to approach any new treatment with caution. If you or a loved one is an older adult, it’s wise to discuss any potential risks or concerns with your healthcare provider. They can help determine the best approach based on individual health needs and any other medications being taken.

Always keep in mind that older adults may have different responses to medications, so regular check-ins with your doctor can 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 may affect you if your kidneys are not functioning properly.

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can help monitor your condition and make any necessary adjustments to your treatment plan.

Hepatic Impairment

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

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help determine the best course of action based on your individual situation.

Drug Interactions

It's 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. Proper storage and careful handling are essential for your safety and the product's reliability.

Additional Information

You should apply the medication to the affected area no more than 3 to 4 times a day. It's important to avoid using it for diaper rash and to consult a doctor if you have any concerns. Make sure to keep the medication away from your eyes and do not exceed the recommended dosage unless directed by a healthcare professional. If you experience any bleeding, or if your condition worsens or does not improve after 7 days, stop using the product and consult a doctor. Additionally, keep this medication out of reach of children, and if swallowed, seek medical help or contact a Poison Control Center immediately.

FAQ

What is this product used for?

This product provides temporary relief of skin itching associated with minor skin irritations and rashes.

How should I apply this product?

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

Can children use this product?

Children under 2 years of age should not use this product without consulting a doctor. For children 2 years and older, it can be applied as directed.

Are there any precautions I should take?

Avoid contact with the eyes and do not exceed the recommended dosage unless directed by a doctor.

What should I do if my condition worsens?

Stop use and consult a doctor if your condition worsens or if symptoms persist for more than 7 days.

Is this product safe for nursing mothers?

Nursing mothers should consult a doctor before using this product, as it may be excreted 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.

Can I use this product for diaper rash?

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

Packaging Info

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

Packaging configurations for Skin a Cool Hydrocortisone Anti-Itch.
Details

Drug Information (PDF)

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

View product document (PDF)

Description

This product is identified by the code 51945-4 and is associated with the package labeling effective as of February 25, 2021. The principal display panel includes a visual representation, which is available in JPEG format. The labeling provides essential information regarding the product's specifications and usage.

Uses and Indications

This drug is indicated for the temporary relief of skin itching. It is specifically effective for the temporary relief of itching associated with minor skin irritations and rashes.

Limitations of Use Other uses of this product should be undertaken only under the advice and supervision of a doctor.

Dosage and Administration

The medication should be applied to the affected area no more than 3 to 4 times daily. For adults and children aged 2 years and older, it is recommended to cleanse the affected area with mild soap and warm water, rinsing thoroughly, or by patting or blotting with an appropriate cleansing pad prior to application, when practical.

For children under 2 years of age, the use of this medication is not recommended; consultation with a healthcare professional is advised. Additionally, for children under 12 years of age, it is also recommended to consult a doctor before use.

Contraindications

The product is contraindicated for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases. Additionally, the recommended daily dosage should not be exceeded unless directed by a physician. The product should not be administered rectally using fingers, mechanical devices, or applicators.

Warnings and Precautions

For external use only. This product is not intended for the treatment of diaper rash; consultation with a healthcare professional is advised in such cases.

When using this product, it is imperative to avoid contact with the eyes. Users should adhere strictly to the recommended daily dosage and should not exceed this amount unless directed by a healthcare provider. In the event of bleeding, it is essential to seek medical advice promptly. Additionally, this product should not be administered rectally using fingers, mechanical devices, or applicators.

Users must discontinue use and consult a healthcare professional 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 also advised not to initiate the use of any other hydrocortisone product without prior consultation with a healthcare provider.

This product should be kept out of reach of children. In the case of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center should be made without delay.

Side Effects

Patients should be aware that this product is for external use only. It is contraindicated for the treatment of diaper rash, and individuals should consult a doctor for appropriate alternatives in such cases.

When using this product, patients are advised to avoid contact with the eyes and not to exceed the recommended daily dosage unless directed by a healthcare professional. In the event of bleeding, it is crucial to consult a doctor promptly. Additionally, patients should refrain from inserting this product into the rectum using fingers or any mechanical device or applicator.

Patients are instructed to stop use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. It is also important not to begin the use of any other hydrocortisone product without prior consultation with a healthcare provider.

This product should be kept out of reach of children. If swallowed, patients should seek medical help or contact a Poison Control Center immediately.

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 Skin a Cool Hydrocortisone Anti-Itch (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Skin a Cool Hydrocortisone 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 medication may be applied to the affected area no more than 3 to 4 times daily. Additionally, children under 12 years of age are advised to consult a doctor prior to use.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population, given the lack of targeted data.

Pregnancy

Pregnant patients are advised to consult a healthcare professional before using this medication. The safety of this product during pregnancy has not been established, and potential risks to fetal outcomes are not well characterized. It is recommended that women of childbearing potential discuss their treatment options with their healthcare provider to ensure the best possible outcomes for both the mother and the fetus.

In pediatric populations, particularly in children under 2 years of age, it is advised to cleanse the affected area when practical. For children under 12 years of age, consultation with a healthcare professional is also recommended prior to use. Proper storage conditions should be maintained at 20-25°C (68-77°F) to ensure the integrity of the product.

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 known.

Renal Impairment

Patients with renal impairment have not been specifically studied in relation to dosage adjustments, special monitoring, or safety considerations for this medication. As such, there is no available information regarding the use of this drug in individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing this medication to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. Consequently, there are no 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.

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 limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to inform patients that this product is not intended for the treatment of diaper rash, and they should consult a doctor for appropriate alternatives.

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 cautioned against using any other hydrocortisone products without prior consultation with a healthcare professional.

While using this product, patients must be reminded to avoid contact with the eyes and not to exceed the recommended daily dosage unless specifically directed by a doctor. In the event of any bleeding, patients should be advised to consult a doctor promptly. Additionally, patients should be informed that the product should not be inserted 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

Patients should apply the medication to the affected area no more than 3 to 4 times daily. It is important for patients to avoid using the product for the treatment of diaper rash and to consult a doctor if needed. Clinicians should advise patients to avoid contact with the eyes and not to exceed the recommended daily dosage unless directed by a healthcare professional.

Patients are also cautioned to seek medical attention promptly in the event of bleeding and 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. Additionally, patients should not begin using any other hydrocortisone product without consulting a doctor. The medication should be kept out of reach of children, and if swallowed, medical help or contact with a Poison Control Center should be sought immediately.

Drug Information (PDF)

This file contains official product information for Skin a Cool Hydrocortisone 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 Skin a Cool Hydrocortisone 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.