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:

Bentlin Products LLC

INN (International Name):

HYDROCORTISONE ACETATE

Composition:

HYDROCORTISONE ACETATE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-itch For temporary relief of itching associated with minor skin irritation, inflammation and rashes due to: - Atopic eczema - Contact dermatitis from soaps, detergents or cosmetics - Seborrheic dermatitis - Psoriasis 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- HYDROCORTISONE ACETATE CREAM
BENTLIN PRODUCTS LLC
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_DRUG FACTS_
ACTIVE INGREDIENT
Hydrocortisone acetate USP 1.0% w/w
PURPOSE
Anti-itch
USES:
For temporary relief of itching associated with minor skin irritation,
inflammation and
rashes due to:
Atopic eczema
Contact dermatitis from soaps, detergents or cosmetics
Seborrheic dermatitis
Psoriasis
Other uses of this product should be only under the advice and
supervision of a doctor
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
For the treatment of diaper rash
On children under the age of 2 except under the supervision of a
doctor
WHEN USING THIS PRODUCT
Avoid contact with the eyes
Do not begin use any other hydrocortisone product unless directed by a
doctor
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. If swallowed get medical help or
contact a Poison
Control Center right away.
DIRECTIONS
ADULTS AND CHILDREN 2 YEARS AND OLDER
Apply to the affected area not more than 3 to 4 times daily.
CHILDREN UNDER 2 YEARS OF AGE
Do not use. Consult a doctor.
OTHER INFORMATION
Store between 20°-25°C (68°-77°F)
INACTIVE INGREDIENTS
caprylic/capric triglyceride, caprytyl glycol, ceteareth-20,
chamomillia recutitia flower
extract, citric acid, glycerin, glyceryl, stearate, palmitic acid.
petrolatum phenoxyethanol,
stearic acid, purified water
QUESTIONS OR COMMENTS?
Call 908 630 9445 weekdays 9:00am to 4:30pm EST or visit us online at
www.exederm.com
PRINCIPAL DISPLAY PANEL - 2 OZ CARTON LABEL
NDC 47832-205-34
EXEDERM
FLARE CONTROL CREAM
FOR ECZEMA & DERMATITIS
NET WT 2 OZ (56g)
1% Hydrocortisone Anti-Itch Cream
®
HYDROCORTISONE ACETATE
hydrocortisone acetate cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:47832-205
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE -
UNII:WI4X0X7BPJ)
HYDROCORTIS