HYDROCORTISONE ACETATE cream

Hydrocortisone Acetate by

Drug Labeling and Warnings

Hydrocortisone Acetate by is a Otc medication manufactured, distributed, or labeled by Bentlin Products LLC, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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)	HYDROCORTISONE ACETATE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PALMITIC ACID (UNII: 2V16EO95H1)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
CHAMOMILE (UNII: FGL3685T2X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47832-205-34	1 in 1 CARTON	01/24/2007
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/24/2007

Labeler - Bentlin Products LLC (832615426)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(47832-205)