Label: PAINKOOLERS TOPICAL ANALGESIC- menthol, unspecified form, capsaicin gel

  • 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 November 30, 2015

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  • DRUG FACTS:

  • ACTIVE INGREDIENTS:

    Menthol  5.00%

    Capsaicin  0.05%

    External Analgesic

  • USES:

    For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, sprains, bruises and strains.

  • WARNINGS:

    For external use only.​

    Use only as directed. Avoid contact with eyes and muccous membranes.

    • Do not cover ​with bandage

    Do not use

    on wounds or damaged skin • ​ Do not use ​in combination with any other external analgesic products • Avoid contact with eyes and maccous membranes •  ​Do not use ​in combination with any external heat source. • ​ Do not use ​on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment

    Keep out of reach of children

    • Consult physician for children under 12

    • Do not use

    if you are allergic or amenthol

    • Stop use

    and ask a doctor id conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days • Or Rash, itching or excessive skin irritation occurs.

  • DIRECTIONS:

    • Adults and children 12 years and over apply to affected area.
    • Change patch 1 to 2 times daily.
    • Children under 12 years, consult physician before use.
  • How to apply:

    • Clean and dry affected area
    • Cut open pouch and remove patch
    • Remove protected film and apply directly to area of pain
    • Apply to affected area not more than 3 times daily
    • Wash hands with soap after applying patch
    • Reseal pouch containing unused patches
  • INACTIVE INGREDIENTS:

    Purified Water,Glycerin,Polyvinyl Alcohol,Sodium Polyacrylate,Propylene Glycol,Polysorbate 80,Sorbitan Stearate,Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aanica Montana Extract, Rosemary Oil,Tartaric Acid,Dihydroxyaluminum Aminoacetate,Titanium Dioxide,Kaolin,Glydant Plus Liquid.

  • Package Labeling:

    label

  • INGREDIENTS AND APPEARANCE
    PAINKOOLERS TOPICAL ANALGESIC 
    menthol, unspecified form, capsaicin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70118-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.05 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    TARTARIC ACID (UNII: W4888I119H)  
    DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    KAOLIN (UNII: 24H4NWX5CO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70118-002-055 in 1 POUCH
    18 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/21/2015
    Labeler - GA Health and Beauty (FOSHAN) Co., Ltd (544333811)
    Establishment
    NameAddressID/FEIBusiness Operations
    GA Health and Beauty (FOSHAN) Co., Ltd544333811repack(70118-002) , relabel(70118-002)
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