Label: EAGLE- menthol capsaicin 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 August 26, 2016

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  • 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:42217-300
    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:42217-300-066 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 - Henan Lingrui Pharmaceutical Co Ltd (530021062)
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