Label: FREDS MEDICATED ANTI ITCH- pramoxine hydrochloride, menthol 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 April 15, 2019

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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

    Armand maic .jpg

    Medicated anti- itch Cream

    Topical analgesic

    Maximum strength pain and Itch relief

  • INGREDIENTS AND APPEARANCE
    FREDS MEDICATED ANTI ITCH 
    pramoxine hydrochloride, menthol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11383-265
    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
    STEARETH-21 (UNII: 53J3F32P58)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11383-265-511 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 - Weeks and Leo, Inc. (005290028)
    Registrant - Weeks and Leo, Inc. (005290028)
    Establishment
    NameAddressID/FEIBusiness Operations
    Weeks & Leo, Inc.005290028manufacture(11383-265)
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