MAKESENSE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [CHERRY HILL SALES CO]

MAKESENSE MAXIMUM STRENGTH (HYDROCORTISONE) CREAM [CHERRY HILL SALES CO]
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NDC 69020-204-14
Set ID 0559c16d-7422-407f-a4cc-401902a26686
Category HUMAN OTC DRUG LABEL
Packager Cherry Hill Sales Co
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredient

    Hydrocortisone 1%

  • Purpose

    Anti-itch

  • Uses

    ■ for temporary relief of itching associated with minor skin irritations and rashes due to: ■ eczema  ■ seborrheic dermatitis ■ psoriasis ■insect bites ■ poison ivy, oak, sumac ■ soaps ■ detergents ■ cosmetics ■ jewelry ■  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 beginuse 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 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

    ■ store at 68-77F (20 to 25C) ■ see carton or tube crimp for lot number and expiration date

  • Inactive Ingredients

    Cetearyl Alcohol, Disodium EDTA, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Sorbitan Stearate, Water

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    MAKESENSE  MAXIMUM STRENGTH
    hydrocortisone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-204
    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)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-204-1414 g in 1 TUBE; Type 0: Not a Combination Product06/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/15/2014
    Labeler - Cherry Hill Sales Co (145959768)

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