HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH)- hydrocortisone acetate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ)

Available from:

Taro Pharmaceuticals U.S.A., Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-itch cream - 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 - 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

Authorization status:

OTC monograph not final

Summary of Product characteristics

HYDROCORTISONE ACETATE ANTIPRURITIC (ANTI-ITCH)- HYDROCORTISONE
ACETATE CREAM
TARO PHARMACEUTICALS U.S.A., INC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
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HYDROCORTISONE 1% CREAM
_DRUG FACTS_
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
rectal bleeding
diaper rash
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.
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
Children under 2 years of age: do not use. consult a doctor
FOR EXTERNAL ANAL ITCHING:
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 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 tem