ANTI-ITCH- hydrocortisone cream

Anti-itch by

Drug Labeling and Warnings

Anti-itch by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each gram)

Hydrocortisone 10mg

Purpose

Antipuritic (Anti Itch)

Uses

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

Warnings

• for external use only
• avoid contact with 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 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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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 a soft cloth before application of this product.
• Children under 12 years of age: consult a doctor.

Other information

• Store at controlled room temperature 68°-77° F (20°-25° C).
• Use only if package is intact.

Inactive ingredients

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

Package Labels

INGREDIENTS AND APPEARANCE

ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-091
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
WATER (UNII: 059QF0KO0R)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MINERAL OIL (UNII: T5L8T28FGP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BENZOIC ACID (UNII: 8SKN0B0MIM)
CHLORPHENESIN (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-091-01	1 in 1 BOX	03/01/2010
1		28.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 53329-091-91	48 in 1 CARTON	03/01/2010
2	NDC: 53329-091-90	1.5 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC: 53329-091-96	144 in 1 CASE	03/01/2010
3		28.4 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	03/01/2010

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Ultra Seal Corporation		085752004	manufacture(53329-091)