FDA Label for Hydrocortisone Acetate Antipruritic (anti-itch)
View Indications, Usage & Precautions
Hydrocortisone Acetate Antipruritic (anti-itch) Product Label
The following document was submitted to the FDA by the labeler of this product Taro Pharmaceuticals U.s.a., Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532
Active Ingredient
Hydrocortisone acetate (equivalent to Hydrocortisone 1%)
Purpose
Anti-itch cream
Uses
- temporary relief of itching associated with minor skin irritations and rashes due to
- eczema
- insect bites
- poison ivy, poison oak, or poison sumac
- soaps
- detergents
- cosmetics
- jewelry
- seborrheic dermatitis
- psoriasis
- external genital and anal itching
- other uses of this product should be only under the advice and supervision of a doctor
Warnings
For external use only
Do Not Use
- in the eyes
- by putting this product into the rectum by using fingers or any mechanical device or applicator
Ask A Doctor Before Use If You Have
- a vaginal discharge
- rectal bleeding
- diaper rash
Otc - When Using
When using this product consult a doctor before exceeding recommended dosage
Stop Use And Ask A Doctor If
- condition gets worse
- condition persists for more than 7 days
- condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 2 years of age and older:
- apply to affected area not more than 3 to 4 times daily
- Adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
Children under 2 years of age: do not use. consult a doctor
For external anal itching:
Children under 12 years of age: consult a doctor
Other Information
- To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
- store at room temperature
- see carton or tube crimp for lot number and expiration date
Inactive Ingredients
cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, white petrolatum
Questions?
Call 1-866-923-4914
Principal Display Panel - 28.4 G Carton
Itch and Rash Relief
Hydrocortisone 1%
Cream
Hydrocortisone Acetate
Antipruritic (Anti-Itch)
MAXIMUM STRENGTH
NET WT 1 oz (28.4 g)
* Please review the disclaimer below.