HYDROCORTISONE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Galentic Pharma (India) Private Limited

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-Itch Temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: - eczema - psoriasis - poison ivy, poison oak, poison sumac - insect bites - detergents - jewelry - seborrheic dermatitis - soaps - external itching and anal itching.

Authorization status:

OTC monograph not final

Summary of Product characteristics

HYDROCORTISONE- HYDROCORTISONE CREAM
GALENTIC PHARMA (INDIA) PRIVATE LIMITED
_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 CREAM
• ACTIVE INGREDIENT
Hydrocortisone 1%
• PURPOSE
Anti-Itch
• USES
Temporarily relieves itching associated with minor skin irritations,
inflammation, and
rashes due to:
eczema
psoriasis
poison ivy, poison oak, poison sumac
insect bites
detergents
jewelry
seborrheic dermatitis
soaps
external itching and anal itching.
• WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
For the treatment of diaper rash. Ask a doctor
For external genital itching if you have a vaginal discharge. Ask a
doctor
WHEN USING THIS PRODUCT
Avoid contact with the eyes
Do not begin use of any other Hydrocortisone product unless you have
asked a
doctor
For external anal itching 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
Symptoms persist for more than 7 days or clear up and occur again
within a few
days
• KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center immediately.
• 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. Ask 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 with external anal itching: ask a
doctor.
• OTHER INFORMATION
Store at 15° to 30°C (59° to 86°F)
Lot No. & Exp.Date: See box or crimp of