WARM SAP PATCH (TOPICAL STARCH) POULTICE [KJI INDUSTRIAL CO LTD]

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WARM SAP PATCH (TOPICAL STARCH) POULTICE [KJI INDUSTRIAL CO LTD]
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NDC 34690-8001-3
Set ID 913f6456-8e51-4fb6-af6e-687585039402
Category HUMAN OTC DRUG LABEL
Packager KJI Industrial Co Ltd
Generic Name
Product Class
Product Number
Application Number PART347
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  • WARNINGS

    Warnings: For external use only
  • DO NOT USE

    Do Not Use
    - on wounds, damaged skin or face
    - if you are allergic to any ingredients of this product
    - with or at the same time as other external product
  • WHEN USING

    When using this product
    - do not use otherwise than directed
    - do not stretch out the adhesive tape
    - do not take out the contents from the patch
    - if patch is ripped, discard immediately
  • STOP USE

    Stop use and ask a doctor if
    - if allergic reaction or irritation occurs
    - if you are pregnant, nursing or under medical treatment

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children
    - if swallowed, get medical help or contact a Poison Control Center right away
  • INDICATIONS & USAGE

    Directions
    Adults and children 4 years of age and over:
    Step 1: Clean and dry area for the patch to be attached
    Step 2: Remove the protective cover sheet and gently apply
    Step 3: Leave it on at least 4 hours before removal
    Children under 4 years of age: Consult a doctor
  • STORAGE AND HANDLING

    Storage
    - Avoid storing product in direct sunlight
    - Keep it in a dry and cool place
  • ACTIVE INGREDIENT

    Active Ingredient:
    Topical Starch 73.9% ........................... Skin Protectant
  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Microcapsule, Tourmaline, Agaricus, Eucalyptus oil, Mugwort extract, Loquat extract, Vitamin C, Chitosan, Polysaccharide
  • PRINCIPAL DISPLAY PANEL

    BOX LABEL
  • INGREDIENTS AND APPEARANCE
    WARM SAP PATCH 
    topical starch poultice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34690-8001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STARCH, CORN (UNII: O8232NY3SJ) (STARCH, CORN - UNII:O8232NY3SJ) STARCH, CORN2.95 g  in 4 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34690-8001-34 g in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/15/2010
    Labeler - KJI Industrial Co Ltd (688453179)
    Registrant - KJI Industrial Co Ltd (688453179)
    Establishment
    NameAddressID/FEIBusiness Operations
    KJI Industrial Co Ltd688453179manufacture
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