Label: MEDICATED ANTI-ITCH WELL AT WALGREENS- menthol 1 % pramoxine hydrochloride 1 % cream

  • Category: HUMAN OTC DRUG LABEL

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 February 15, 2018

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  • Active ingredients                                     Purpose

    Menthol – 1.00%                                        Pain Reliever   
    Pramoxine Hydrochloride – 1.00%            External Analgesic

  • PURPOSE

  • INDICATIONS & USAGE

    ​Uses​ For temporarily relief of pain and itching associated with:• sunburn • minor burns • scrapes • insect bites • minor skin irritation • minor cuts • rashes due to poison ivy, oak & sumac

  • WarningsFor external use only

    ​Do not use on​ • deep or puncture wounds • animal bites • serious burns • large areas of the body

    When using this product • Avoid contact with eyes • not for prolonged use

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persisit more than 7 days or clear up and occur again within a few days

    Keep out of reach of the children. If product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    • Adults and children 2 years of age and older:​ apply to the affected area no more than 4 times daily
    • Children under 2 years of age: consult a doctor
  • Other information

    Store at room temperature.

  • Inactive ingredients

    Water, Propylene Glycol, Petrolatum, Stearyl Alcohol, Aloe Barbadensis Leaf Juice, Sodium Acrylates Copolymer, Steareth-21, Mineral Oil,
    Steareth-2, Tocopheryl Acetate, Thymol, Eucalyptol, Methyl Salicylate, PPG-1 Trideceth-6, Diazolidinyl Urea, Disodium EDTA, Triethanolamine,
    Iodopropynyl Butylcarbamate

  • Questions or comments?1-866-483-2846

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    MEDICATED ANTI-ITCH  WELL AT WALGREENS
    menthol 1 % pramoxine hydrochloride 1 % cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-3231
    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
    Water (UNII: 059QF0KO0R)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Steareth-21 (UNII: 53J3F32P58)  
    Mineral Oil (UNII: T5L8T28FGP)  
    Steareth-2 (UNII: V56DFE46J5)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Thymol (UNII: 3J50XA376E)  
    Eucalyptol (UNII: RV6J6604TK)  
    Methyl Salicylate (UNII: LAV5U5022Y)  
    PPG-1 Trideceth-6 (UNII: 1K7417JX6Q)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-3231-021 in 1 CARTON09/15/2014
    156 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 finalpart34809/15/2014
    Labeler - Walgreens (008965063)
    Registrant - Product Quest Mfg (927768135)
    Establishment
    NameAddressID/FEIBusiness Operations
    Product Quest Mfg927768135manufacture(0363-3231) , label(0363-3231)
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