Label: BAMBOO SAP PATCH- topical starch poultice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 11, 2010

If you are a consumer or patient please visit this version.

  • 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% ........................... Skin Protectant
  • INACTIVE INGREDIENT

    Inactive Ingredients:
    Bamboo Vinegar, Tourmaline, Chitosan, PearlStone, Highly purified silica, Polyhydric alcohol, Mugwort extract
  • PRINCIPAL DISPLAY PANEL

    BOX LABEL
  • INGREDIENTS AND APPEARANCE
    BAMBOO SAP PATCH 
    topical starch poultice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34690-9001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STARCH, CORN (UNII: O8232NY3SJ) (STARCH, CORN - UNII:O8232NY3SJ) STARCH, CORN2.92 g  in 4 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34690-9001-64 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