SCHEIN HYDROCORTISONE- hydrocortisone cream

Schein Hydrocortisone by

Drug Labeling and Warnings

Schein Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Henry Schein, Inc., Ultra Seal Corporation, ULTRAtab Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (in each gram): Hydrocortisone USP 10mg

PURPOSE

Antipruritic (Anti-Itch)

INDICATIONS & USAGE

Uses: For the temporary relief of itching associated with minor skin irritations, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatits, psoriasis, and for external genital, feminine and anal itching. Other uses of this product should be only under the advice and supervision of a doctor,

WARNINGS

Warnings: For external use only. Avoid contact with the eyes.  Do not use and consult a doctor for the treatment of diaper rash, if you have a vaginal discharge. If condition worsens, or if the symptoms persist for more than 7 days, or clear up and occur again within a few days stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor. Do not exceed the recommended daily dosage unless directed by the doctor. In case of bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

DOSAGE & ADMINISTRATION

Directions: For 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 water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before application of this product. Children under 12 years of age: consult a doctor.

INACTIVE INGREDIENT

Inactive Ingredients: benzoic acid, chlorphenesin,  citric acid, glycerin, glycerol monostearate, methyl paraben, mineral oil, petrolatum, phenoxyethanol, polysorbate 80,  purified water, titanium dioxide and trisodium citrate.

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.

PREGNANCY OR BREAST FEEDING

If pregnant or breast-feeding, ask a health professional before use.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SCHEIN HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0404-0370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BENZOIC ACID (UNII: 8SKN0B0MIM)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
CHLORPHENESIN (UNII: I670DAL4SZ)
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0404-0370-48	1 in 1 CARTON	05/04/2015
1	NDC: 0404-0370-28	28 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	04/05/2011

Labeler - Henry Schein, Inc. (012430880)

Registrant - Ultra Seal Corporation (944090448)

Establishment
Name	Address	ID/FEI	Business Operations
ULTRAtab Laboratories, Inc.		151051757	manufacture(0404-0370)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		944090448	pack(0404-0370)