Ana Cool Rapid Soothing Cooling Formula
Ana Cool Rapid Soothing Cooling Formula is an FDA drug label for the active ingredient HYDROCORTISONE manufactured by Ana-Cool, LLC administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231105.
Generic: HYDROCORTISONE
Manufacturer: Ana-Cool, LLC
Product Type: HUMAN OTC DRUG
Route: TOPICAL
Dosage Form:
NDC: 70288-714
Application: M017
Effective: 20231105
Active Ingredients: Active Ingredients: Hydrocortisone 1.0% Anti -itch
Indications & Usage
Uses: Temporarily relief of external anal itching Temporary relief of itching associated with minor skin irritations and rashes Other uses of this product should be only under the advice and supervision of a doctor
Dosage & Administration
Directions: cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before the applicationof this product Adults: apply to the affected area not more than 3 to 4 times daily. Adults and children 12 years of age and older: do not use, consult a doctor Children under 12 years of age:
Contraindications
Not available.
Warnings
Warnings: For external use only. Do not use for the treatment of diaper rash. Consult a doctor. When using this product, • avoid contact with the eyes • do not exceed the recommended daily dosage unless directed by a doctor • do not put into the rectum by using fingers or any mechanical device or applicator Stop use and ask a doctor if • bleeding occurs • condition worsen • symptoms persist for more than 7 days or clear up occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Centre right away
Adverse Reactions
Not available.
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