QUALITY CHOICE HYDROCORTISONE MAXIMUM STRENGTH- hydrocortisone cream

Quality Choice Hydrocortisone Maximum Strength by

Drug Labeling and Warnings

Quality Choice Hydrocortisone Maximum Strength by is a Otc medication manufactured, distributed, or labeled by Chain Drug Marketing Association Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                         Purpose

Hydrocortisone 1%................................................................... Anti-itch

PURPOSE

Uses

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

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

WHEN USING

When using this product

• avoid contact with eyes
• do not use more than directed unless told to do so by a doctor
• do not put directly into the rectum by using fingers or any mechanical device or applicator

STOP USE

Stop use and ask a doctor if

• conditions worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
• rectal bleeding occurs

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.

INDICATIONS & USAGE

Directions

• for itching of skin irritation, inflammation, and rashes:
• 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: ask a doctor
• for external anal and genital itching, adults:
• when practical, clean 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 applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: ask a doctor

STORAGE AND HANDLING

Other information

• Store at between 20° to 25°C (68°-77°F)
• Lot No. & Exp. Date: see box or see crimp of tube

INACTIVE INGREDIENT

Inactive ingredients

butylated hydroxytoluene, cetanol, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

DOSAGE & ADMINISTRATION

DISTRIBUTED BY C.D.M.A., INC.

43157 W. NINE MILE

NOVI, MI 48376-0995

www.qualitychoice.com

MADE IN KOREA

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

QUALITY CHOICE HYDROCORTISONE MAXIMUM STRENGTH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63868-596
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
PARAFFIN (UNII: I9O0E3H2ZE)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63868-596-28	1 in 1 CARTON	01/16/2015
1		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	01/15/2015

Labeler - Chain Drug Marketing Association Inc (011920774)