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Ana Cool Rapid Soothing Cooling Formula

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Active ingredient
Hydrocortisone 10 mg/1 g
Other brand names
Drug class
Corticosteroid
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2015
Label revision date
November 5, 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 2015
Label revision date
November 5, 2023
Manufacturer
Ana-Cool, LLC
Registration number
M017
NDC root
70288-714
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

You may find this product helpful for temporarily relieving external anal itching and the itching associated with minor skin irritations and rashes. It is designed to provide quick comfort for these specific issues. However, for any other uses, it is important to consult with a doctor for proper guidance and supervision.

Uses

If you're experiencing external anal itching or minor skin irritations and rashes, this product can provide temporary relief. It's designed to help soothe discomfort and reduce itching, allowing you to feel more comfortable.

However, for any other uses beyond these indications, it's important to consult with your doctor for advice and supervision. This ensures that you use the product safely and effectively for your specific needs.

Dosage and Administration

To use this product effectively, start by cleansing the affected area. You can do this by gently patting or blotting the skin with a suitable cleansing wipe. After cleansing, make sure to dry the area by patting or blotting it with a tissue or a soft cloth before applying the product.

For adults and children aged 12 years and older, you should apply the product to the affected area no more than 3 to 4 times a day. If the person using the product is under 12 years old, it’s important to consult a doctor before use. This ensures safety and proper care for younger individuals.

What to Avoid

It's important to use this medication safely. You should not use it for treating diaper rash; always consult your doctor for appropriate treatment options. Additionally, avoid starting any other hydrocortisone product without first discussing it with your healthcare provider.

While using this product, be cautious to prevent contact with your eyes and do not exceed the recommended dosage unless directed by your doctor. If you experience any bleeding, notice that your condition worsens, or if symptoms persist for more than seven days or return shortly after improvement, stop using the product and consult your doctor. Lastly, do not insert the medication into the rectum using fingers or any device.

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 exceed the recommended daily dosage unless directed by a doctor. If you experience any bleeding, if your condition worsens, or if symptoms persist for more than 7 days or return shortly after improvement, stop using the product and consult a doctor.

Additionally, this product is for external use only and should not be used for treating diaper rash. Keep it out of reach of children, and if swallowed, seek medical help or contact a Poison Control Centre immediately.

Warnings and Precautions

This product is for external use only, so please avoid using it on diaper rash and consult your doctor if you have any questions. 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. Additionally, do not insert it into the rectum using fingers or any device.

You should stop using the product and contact your doctor if you experience any bleeding, if your condition worsens, or if your symptoms last more than 7 days or return after clearing up. It's important to keep this product out of reach of children. If swallowed, seek medical help or contact a Poison Control Centre immediately.

Overdose

If you or someone else has swallowed too much of a medication, it’s important to act quickly. You should seek medical help immediately or contact a Poison Control Centre. They can provide guidance on what to do next.

Signs of an overdose can vary, but it’s crucial to be aware of any unusual symptoms. If you notice anything concerning, don’t hesitate to reach out for help. Remember, acting fast can make a significant difference in ensuring safety and health.

Pregnancy Use

The product does not have specific information regarding its use during pregnancy. There are no explicit safety concerns, contraindications (situations where the product should not be used), or dosage changes recommended for pregnant individuals. Additionally, no special precautions are noted for use during pregnancy.

If you are pregnant or planning to become pregnant, it's always best to consult with your healthcare provider before using any medication to ensure it is safe for you and your baby.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you are considering this medication for your child, it's important to know that it is not recommended for children under 12 years of age. If your child is younger than this age, please consult a doctor for advice on appropriate treatment options. Always prioritize your child's safety and well-being by seeking professional guidance when it comes to their health.

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. Since older adults may have different health needs and responses to medications, you should always consult with a healthcare provider before starting any new medication. They can help determine the best approach for you or your loved one, considering any existing health conditions or medications that may interact.

Remember, your safety and well-being are the top priority, so don’t hesitate to ask questions and discuss any concerns with your doctor.

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 should be used if you have hepatic impairment (liver issues).

Before starting any new medication, including this one, you should discuss your liver health with your healthcare provider. They can help determine the best approach for your treatment and ensure your safety.

Drug Interactions

It's important to talk to your healthcare provider before starting any new hydrocortisone product. Using another hydrocortisone product without consulting a doctor can lead to potential complications or reduced effectiveness of your treatment.

While there are no specific interactions with other drugs or laboratory tests mentioned, keeping your healthcare provider informed about all medications and tests you are undergoing is crucial. This ensures your safety and helps them provide the best care tailored to your needs.

Storage and Handling

To ensure the best performance of your product, store it at a temperature between 20 to 25 °C (68 to 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. Always follow any specific disposal instructions provided to ensure safe and responsible disposal of any components.

Additional Information

You should apply the medication topically to the affected area, using it no more than 3 to 4 times a day. This means you can directly put the medication on the skin where you need relief. There are no additional details available regarding laboratory tests, abuse potential, or patient counseling.

FAQ

What is this product used for?

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

How should I apply this product?

Cleanse the affected area by patting or blotting with a cleansing wipe, then gently dry before applying. Adults and children 12 years and older can apply it to the affected area up to 3 to 4 times daily.

Can children use this product?

Children under 12 years of age should not use this product without consulting a doctor.

Are there any contraindications for this product?

Do not use this product for the treatment of diaper rash; consult a doctor instead.

What should I do if symptoms persist?

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

What precautions should I take when using this product?

Avoid contact with the eyes, do not exceed the recommended dosage, and do not put it into the rectum using fingers or any device.

What should I do if I accidentally swallow this product?

Keep this product out of reach of children. If swallowed, get medical help or contact a Poison Control Centre immediately.

Is this product safe to use during pregnancy or while nursing?

The product has not been specifically mentioned for use during pregnancy or nursing, so consult a doctor for advice.

What is the storage requirement for this product?

Store the product at 20 - 25 °C (68-77°F).

Packaging Info

Below are the non-prescription pack sizes of Ana Cool Rapid Soothing Cooling Formula (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ana Cool Rapid Soothing Cooling Formula.
Details

Drug Information (PDF)

This file contains official product information for Ana Cool Rapid Soothing Cooling Formula, 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 specific description details are provided in the text.

Uses and Indications

This drug is indicated for the temporary relief of external anal itching. It is also indicated for the temporary relief of itching associated with minor skin irritations and rashes.

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

Dosage and Administration

The affected area should be cleansed by patting or blotting with an appropriate cleansing wipe. After cleansing, gently dry the area by patting or blotting with tissue or a soft cloth prior to the application of the product.

For adults and children aged 12 years and older, the product should be applied to the affected area no more than 3 to 4 times daily. It is important to adhere to this frequency to ensure optimal results.

For children under 12 years of age, the product is not recommended for use. Consultation with a healthcare professional is advised before application in this age group.

Contraindications

The use of this product is contraindicated in the treatment of diaper rash; consultation with a healthcare professional is advised.

Additionally, the initiation of any other hydrocortisone product should only occur after consulting a doctor.

Patients should discontinue use and seek medical advice if bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days or resolve and then recur within a few days.

While using this product, it is important to avoid contact with the eyes, exceeding the recommended daily dosage unless directed by a healthcare professional, and inserting the product into the rectum using fingers or any mechanical device or applicator.

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 utilizing 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 specifically directed by a healthcare provider. Additionally, the product should not be administered rectally using fingers, mechanical devices, or applicators.

Patients are advised to discontinue use and seek medical advice if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days. Should symptoms resolve and then reappear within a few days, it is essential to consult a healthcare professional before resuming use of any other hydrocortisone product.

To ensure safety, this product must be kept out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is recommended.

Side Effects

Patients using this product should be aware that it is intended for external use only. It is contraindicated for the treatment of diaper rash, and consultation with a healthcare professional is advised in such cases.

During the use of this product, patients are cautioned to avoid contact with the eyes and to adhere strictly to the recommended daily dosage. Exceeding this dosage should only occur under the guidance of a healthcare provider. Additionally, patients should refrain from inserting the product into the rectum using fingers or any mechanical device or applicator.

Patients are advised to discontinue use and seek medical attention if any of the following occur: bleeding, worsening of the condition, or if symptoms persist for more than 7 days. If symptoms resolve and then recur within a few days, patients should not resume use of any other hydrocortisone product without consulting a doctor.

It is imperative to keep this product out of reach of children. In the event of accidental ingestion, immediate medical assistance should be sought, or contact with a Poison Control Centre is recommended.

Drug Interactions

The initiation of any additional hydrocortisone product should only occur after consultation with a healthcare professional. This precaution is essential to avoid potential adverse effects or interactions that may arise from concurrent use.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Ana Cool Rapid Soothing Cooling Formula (hydrocortisone). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Ana Cool Rapid Soothing Cooling Formula.
Details

Pediatric Use

Pediatric patients under 12 years of age should not use this medication without consulting a healthcare professional. It is important for healthcare providers to evaluate the appropriateness of treatment in this age group, considering potential risks and the need for alternative therapies.

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

The product has not been specifically studied for use during pregnancy, and there are no explicit statements regarding safety concerns, contraindications, or dosage modifications for pregnant patients. As such, healthcare professionals should exercise caution when considering this product for women of childbearing potential. Given the lack of data, the potential risks to fetal outcomes remain undetermined. It is advisable for healthcare providers to weigh the benefits against any potential risks when prescribing this product to pregnant individuals.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

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 relation to this drug. 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 intervention is crucial. If the substance is ingested, it is imperative to seek medical assistance or contact a Poison Control Centre without delay.

Healthcare professionals should be aware that prompt action can significantly influence the outcome of an overdosage situation. Symptoms of overdosage may vary depending on the specific substance involved; therefore, a thorough assessment of the patient's condition is essential.

Management procedures should include supportive care and symptomatic treatment as necessary. Continuous monitoring of the patient's vital signs and clinical status is recommended to address any complications that may arise.

In summary, swift action and appropriate medical response are vital in managing cases of overdosage to ensure patient safety and effective treatment.

Nonclinical Toxicology

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

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Centre 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.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any bleeding occurs, if the condition worsens, or if symptoms persist for more than 7 days. Patients should also be made aware that if symptoms clear up and then recur within a few days, they should seek medical advice before resuming use. Additionally, patients should not begin using any other hydrocortisone product without prior consultation with a healthcare professional.

While using this product, patients must be cautioned to avoid contact with the eyes. They should not exceed the recommended daily dosage unless specifically directed by a doctor. Furthermore, patients should be advised against inserting the product 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 to 25 °C (68 to 77 °F) to maintain its integrity and efficacy. Proper storage conditions must be adhered to, ensuring that the product is kept in a suitable container that protects it from environmental factors. Special handling requirements should be observed to prevent any compromise to the product's quality.

Additional Clinical Information

The medication is administered topically, with a recommended application frequency for adults of no more than 3 to 4 times daily to the affected area. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Ana Cool Rapid Soothing Cooling Formula, 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 Ana Cool Rapid Soothing Cooling Formula, 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.