QUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]

QUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH (HYDROCORTISONE) CREAM [CHAIN DRUG MARKETING ASSOCIATION INC]
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NDC 63868-594-28
Set ID a47b4b0b-e78d-43b2-bc70-a4777186ab63
Category HUMAN OTC DRUG LABEL
Packager Chain Drug Marketing Association Inc
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    Active ingredient                                                                     Purpose

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

  • PURPOSE

    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
    • for temporary relief of 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 the 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 ay mechanical device or applicator
  • STOP USE

    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, and do not begin use of any other hydrocortisone proudct unless you have consulted a doctor
    • rectal bleeding occurs
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of the 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: consult a doctor
    • for external anal and genital itching, adults:
    • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
    • gently dry by patting or blotting with toilet tissue or soft cloth before applying
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: consult a doctor
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients

    aloe vera gel ascorbic acid, butylated hydroxytoluene, cetanol chamomile oil, liquid paraffin, methylparaben, polyoxyethylene cetylether, propylene glycol, propylparaben, purified water, retinol palmitate oil, sodium hydroxide, sorbitan monostearate, stearyl alcohol, tocopheryl acetate

  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MAXIMUM STRENGTH ANTI ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-594
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-594-281 in 1 CARTON01/20/2015
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/19/2015
    Labeler - Chain Drug Marketing Association Inc (011920774)

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