EAGLE (MENTHOL CAPSAICIN) PATCH [BORDEN COMPANY PTE LIMITED]

EAGLE (MENTHOL CAPSAICIN) PATCH [BORDEN COMPANY PTE LIMITED]
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NDC 43405-882-06
Set ID 39a6bfd1-057d-743a-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Borden Company PTE Limited
Generic Name
Product Class
Product Number
Application Number PART348
  • Active Ingredients

    Capsaicin 0.0625%

    Menthol 3.4%

  • Purpose

    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 Avoid getting into the eyes or on mucous membranes. This product containsdry natural rubber which may cause allergic reactions

    Caution: The Packaging of this product Contains Dry Natural Rubber

  • When using this product

    ■ do not appply to wounds or damaged skin ■ do not bandage tightly ■ do not use otherwise than as directed ■ do not use on children under 12 years of age with arthritis like conditions

  • 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 ■ pain persists for more than 10 days ■ redness is present

  • Keep out of reach of children

    to avoid accidental poisoning. In case of accidental ingestion, contact a doctor or Poison Control Center immediately

  • Directions

    ■ remove patch from packet ■ cut patch to size ■ peel off protective backing and apply adhesive side to affected area

    adults and children 2 years of age and older apply to affected area not more than 3 to 4 times daily

    children under 2 years of age do not use, consult a doctor

  • Other Information

    ■ store in a cool place away from sunlight

    ■ keep unused plasters in the original packaging

  • Inactive Ingredients

    beeswax, gum resin, lanolin, rubber and zinc oxide

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    EAGLE 
    menthol capsaicin patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43405-882
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0625 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL3.4 g
    Inactive Ingredients
    Ingredient NameStrength
    BOSWELLIA SACRA WHOLE (UNII: 8O600AZL0W)  
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43405-882-066 in 1 PACKET; Type 0: Not a Combination Product08/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2016
    Labeler - Borden Company PTE Limited (595109711)

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