ZENOL COOL (METHYL SALICYLATE) POULTICE [GREEN CROSS CORP]

ZENOL COOL (METHYL SALICYLATE) POULTICE [GREEN CROSS CORP]
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NDC 61476-100-01
Set ID ea9916b2-85e4-4626-9641-53d5398f7342
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, titanium oxide, kaolin, carboxymethylcellulose sodium, sodium polyacrylate, dired aluminum hydroxide gel, disodium edetate hydrate, gelatin, tartaric acid, polysorbate 80, sorbitan sesquioleate, nikazole TS-620, concentrated glycerin, borneol-p, rose incense, purified water, nonwoven fabric, polypropylene film


  • PURPOSE

    for the temporary relief of sore muscles, sprains, bruises, shoulder pain, arthralgia, backache, neuralgia, rheumatic pain and fracture pain


  • 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 COOL 
    methyl salicylate poultice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61476-100
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE160 mg  in 17 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:61476-100-0117 g in 1 PATCH; Type 0: Not a Combination Product11/23/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/23/201311/26/2023
    Labeler - Green Cross Corp (687760561)
    Establishment
    NameAddressID/FEIBusiness Operations
    Green Cross Corp689852033manufacture(61476-100)

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