LUCKY SUPERSOFT MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [DELTA BRANDS, INC]

LUCKY SUPERSOFT MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [DELTA BRANDS, INC]
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NDC 20276-102-14
Set ID 9a9f93b7-2a33-4465-993d-62fa111c2cfd
Category HUMAN OTC DRUG LABEL
Packager Delta Brands, Inc
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

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

  • Warnings

    For external use only

  • Do not use

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

  • 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 and ask a doctor if

    ■ the condition worsens, symptoms persist for more than 7 days or clear up and occur again wihin a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor ■ rectal bleed occurs

  • Keep out of reach of children

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

  • 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

  • Other information

    do not use if tube seal under cap is broken, missing or if the tube tip is cut prior to opening

  • Inactive ingredients

    aloe barbadensis leaf juice, aluminum sulfate, beeswax, calcium acetate, cetearyl alcohol, dextrin, glycerin, maltodextrin, methylparaben, mineral oil, petrolatum, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    LUCKY SUPERSOFT  MAXIMUM STRENGTH
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-102
    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)  
    ALUMINUM SULFATE (UNII: 34S289N54E)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CALCIUM ACETATE (UNII: Y882YXF34X)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ICODEXTRIN (UNII: 2NX48Z0A9G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-102-1414 g in 1 TUBE; Type 0: Not a Combination Product01/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/31/2015
    Labeler - Delta Brands, Inc (102672008)

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