ZENOL MILD HOT (METHYL SALICYLATE) POULTICE [GREEN CROSS CORP]

ZENOL MILD HOT (METHYL SALICYLATE) POULTICE [GREEN CROSS CORP]
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NDC 61476-101-01
Set ID 91cb5792-dd51-4c59-aa06-41959a0c6b2c
Category HUMAN OTC DRUG LABEL
Packager Green Cross Corp
Generic Name
Product Class
Product Number
Application Number PART348
  • ACTIVE INGREDIENT

    methyl salicylate


  • INACTIVE INGREDIENT

    l-menthol, dl-camphor, thymol, diphenhydramine hydrochloride, vanillyl nonylamide, gelatin, concentrated glycerin, zinc oxide, titanium oxide, carboxymethylcellulose sodium, sodium polyacrylate, sodium metaphosphate, purified lanolin, polyoxyetheylene castor oil, phosphoric acid, ferric oxide, rose incense, purified water, nonwoven fabric, polypropylene film


  • PURPOSE

    for the temporary relief of shoulder pain, backache, neuralgia etc

  • KEEP OUT OF REACH OF CHILDREN

    keep out or reach of the children


  • INDICATIONS & USAGE

    step 1:  remove the colored protective sheet from the adhesive tape strip
    step 2: attach the cotton side of Zenol medicated patch to the adhesive tape
    step 3: remove the transparent protective film from the patch, and also the remainder of the colored protective sheet (the two strips with arrows on the side)
    step 4: apply one or twice daily or as needed, to the affected skin surface
    step 5: following the use, tightly close and fold the open end of the pack, in order to preserve the efficacy of the remaining patch


  • WARNINGS

    1. while skin irritations such as redness, eruption, or itchiness are uncommon, but if they would occur, discontinue usage and consult a physician or a pharmacist
    2. if painful symptoms do no improve after application for several days, discontinue usage and consul with a physician or a pharmacist


  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    package label
  • INGREDIENTS AND APPEARANCE
    ZENOL MILD HOT 
    methyl salicylate poultice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61476-101
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE105 mg  in 17.5 g
    Inactive Ingredients
    Ingredient NameStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61476-101-0117.5 g in 1 PATCH; Type 0: Not a Combination Product12/03/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/03/201302/02/2023
    Labeler - Green Cross Corp (687760561)
    Establishment
    NameAddressID/FEIBusiness Operations
    Green Cross Corp689852033manufacture(61476-101)

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