FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [FRED'S INC.]

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FREDS MEDICATED ANTI ITCH (PRAMOXINE HYDROCHLORIDE, MENTHOL) CREAM [FRED'S INC.]
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NDC 55315-265-01
Set ID 85b98646-de35-7831-e053-2991aa0a6082
Category HUMAN OTC DRUG LABEL
Packager Fred's Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredient

    Menthol 1%

    Pramoxine hydrochloride 1%

  • Uses

    for the temporary relief of pain and itching due to: minor burns, sunburn, minor cuts, scrapes, insect bites, minor skin irritations ,minor rashes due to poison ivy, poison oak, or poison sumac

  • Purpose

    Topical anagesic

  • Warnings

    When using this product

    do not get into eyes

    Keep out of reach of children

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

  • Other Information

    store at controlled room temperature

  • Directions

    adults and children 2 years and older: apply to affected area not more than 3 to 4 times daily

    children under 2 years: consult a doctor

  • DOSAGE & ADMINISTRATION

    Adults and Children 2 years and older: Apply to affected are not more than 3 to 4 times daily.

  • Inactive Ingredients

    aloe barbadensis (aloe vera) leaf juice, diazolidinyl urea, edetate disodium, eucalyptus oil, methylparaben, methyl salicylate, mineral oil, PPG-1 trideceth-6, propylene glycol, propylparaben, purified water, sodium acrylates copolymer, steareth-21, stearyl alcohol, tocopheryl acetate, trolamine, white petrolatum

  • PRINCIPAL DISPLAY PANEL

    Freds Medicated.jpgFreds's Medicated Anti Itch Cream

    Topical Analgesic

    With Aloe and Vitamine E

  • INGREDIENTS AND APPEARANCE
    FREDS MEDICATED ANTI ITCH 
    pramoxine hydrochloride, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-265
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    STEARETH-21 (UNII: 53J3F32P58)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55315-265-011 in 1 CARTON04/13/2014
    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 finalpart34804/13/2014
    Labeler - Fred's Inc. (005866116)
    Registrant - Weeks and Leo, Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo, Inc.005290028manufacture(55315-265)
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