Label: QUALITY CHOICE ANTI-ITCH- hydrocortisone cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 10, 2019

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  • 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
    • jewelry
    • insect bites
    • soaps
    • cosmetics
    • detergents
    • seborrheic dematitis
    • poison ivy, oak, sumac
    • temporarily relieves external anal and genital itching
    • other uses of this product should only be under the advise 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.
    • more than directed unless directed by a doctor
  • WHEN USING

    When using this product

    • avoid contact with eyes
    • do not put directly into the rectum by using fingers or any mechanical device or applicator
  • STOP USE

    Stop use and ask a doctor

    • 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 product unless you have asked a doctor
    • rectal bleeding occurs
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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 warm water and rinse thoroughly
    • gently dry by patting or blotting with a 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 room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera leaf, aluminum sulfate octadecahydrate, calcium acetate, monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax

  • DOSAGE & ADMINISTRATION

    Distributed by: C.D.M.A., Inc.

    43157 W 9 Mile Rd

    Novi, MI 48375

    www.qualitychoice.com

    Made in China

  • PRINCIPAL DISPLAY PANEL

    99259

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE ANTI-ITCH 
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-693
    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
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINIUM SULFATE OCTADECAHYDRATE (UNII: TCS9L00G8F)  
    CALCIUM ACETATE MONOHYDRATE (UNII: 7ZA48GIM5H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-693-281 in 1 CARTON07/10/2019
    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 finalpart34807/10/2019
    Labeler - United Exchange Corp.Chain Drug Marketing Association Inc. (011920774)
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