Label: KGS BAO ZHEN GAO MEDICATED PLASTER EXTRA STRENGTH- methyl salicylate menthol camphor patch

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 27, 2016

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  • Active Ingredients

    Camphor 11%

    Menthol 9%

    Methyl Salicylate 13%

  • Purpose

    External Analgesic

    External Analgesic

    External Analgesic

  • Uses

    For the temporarily relief of minor pains and aches of muscles and joints associated with ■ simple backache ■ arthritis ■ strains

    ■ bruises ■ sprains

  • Warnings

    For external use only

    Do not use

    ■ on wounds or damaged skin ■on children under 12 years of age with arthritis like conditions

  • When using this product

    ■ avoid contact with the eyes or on mucus membranes ■ do not bandage tightly ■ do not use otherwise than as directed

  • Stop use and ask a doctor if

    ■ condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days ■ redness is present

  • Keep out of reach of children

    in case of accidental ingestion, contact a Poison Control Center immediately

  • Directions

    ■ Adults and children 12 years of age and older remove the clear film backing and apply to affected area not more than 3 to 4 times daily

    ■ Children under 12 years of age consult a doctor before using

    ■ Use caution when applying to hairy skin areas, highly adhesive plaster can hurt when removing

  • Other Information

    ■ Store at 68-77F (20-25C)

  • Inactive Ingredients

    Chinese Wild Ginger, Chinese Sweet Gum Resin

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    KGS BAO ZHEN GAO  MEDICATED PLASTER EXTRA STRENGTH
    methyl salicylate menthol camphor patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70551-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE14 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL7 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)7 g
    Inactive Ingredients
    Ingredient NameStrength
    LIQUIDAMBAR STYRACIFLUA RESIN (UNII: P41GWD11CX)  
    ASARUM SIEBOLDII (UNII: T1134STW1K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70551-002-055 in 1 BOX; Type 0: Not a Combination Product05/09/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/09/2016
    Labeler - Huangshi Likang Pharmaceutical Co.,Ltd. (545799025)
    Registrant - Huangshi Likang Pharmaceutical Co.,Ltd. (545799025)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huangshi Likang Pharmaceutical Co.,Ltd.545799025manufacture(70551-002)
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