Label: ANTI-ITCH- menthol and pramoxine hydrochloride 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 July 1, 2016

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  • ACTIVE INGREDIENT

    Active ingredients

    Menthol 1%

    Pramoxine hydrochloride 1%

  • PURPOSE

    Purpose

    Anti-itch, Pain relief

  • INDICATIONS & USAGE

    Uses

    for temporary relief of pain and itching associated with:

    • minor skin irritations
    • minor cuts
    • minor burns
    • rashes due to poison ivy, poison oak or poison sumac
    • scrapes
    • insect bites
  • WARNINGS

    Warnings

    For external use only

    Do not use on

    • deep or puncture wounds
    • animals bites
    • serious burns
    • large areas of the body

    When using this product

    • do not get into eyes or nose
    • not for prolonged use

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days
    • if redness, irritation, swelling or pain persists or increases

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 2 years and older: apply to affected area up to 3 or 4 times daily

    children under 2 years: consult a doctor

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera (aloe barbadensis) leaf juice, diazolidinyl urea, disodium EDTA, eucalyptol, iodopropynyl butylcarbamate, methyl salicylate, mineral oil (parraffinum liquidum), petrolatum, PPG-1 trideceth-6, propylene glycol, sodium acrylates copolymer, steareth-21, stearyl alcohol, thymol,   tocopheryl acetate (vitamin E), triethanolamine, water

  • SPL UNCLASSIFIED SECTION

    Other information

    • store at room temperature
    • for lot no. and exp. date, see crimp of tube or see box
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL

    ANTI-ITCH CREAM

    NET WT 1 OZ (28 g)

    label of anti-itch

  • INGREDIENTS AND APPEARANCE
    ANTI-ITCH 
    menthol and pramoxine hydrochloride cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-407
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 g  in 100 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PPG-1 TRIDECETH-6 (UNII: 1K7417JX6Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARETH-21 (UNII: 53J3F32P58)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    THYMOL (UNII: 3J50XA376E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55910-407-0328 g in 1 TUBE; Type 0: Not a Combination Product06/30/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/30/2016
    Labeler - Dolgencorp, Inc. (068331990)
    Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)
    Establishment
    NameAddressID/FEIBusiness Operations
    Anicare Pharmaceuticals Pvt. Ltd916837425manufacture(55910-407)
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