SKIN A COOL Hydrocortisone Anti-Itch

HYDROCORTISONE TOPICAL HUMAN OTC DRUG

SKIN A COOL Hydrocortisone Anti-Itch 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 20231110.

Generic name
HYDROCORTISONE
Manufacturer
Ana-Cool, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
70288-173
Application
M017
Label effective
20231110

Active ingredients

Active Ingredients: Hydrocortisone 1.0% Purpose Anti-itch

Indications & Usage

Uses: Temporary relief of skin itching. The temporary relief of itching associated with minor skin irritations and rashes. Other uses of this product should be only under the advise and supervision of a doctor.

Dosage & Administration

Directions: Apply to affected area not more than 3 to 4 times daily. Adults and children 2 years of age and older: Do not use, consult a doctor. Children under 2 years of age: When practical, cleanse the affected area "(selected one or both of the following: with mild soap and warm water and rinse thoroughly". or "by patting or blotting with an appropriate cleansing pad").: Adults: consult a doctor. Children under 12 years of age:

Contraindications

Not available.

Warnings

Warnings: For external use only. Do not use for 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. In case of bleeding, consult a doctor promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator. Stop use and ask a doctor if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocorstisone product unless you have consulted a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Not available.

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