Label: PAIN TERMINATOR ANALGESIC- menthol and methyl salicylate patch

  • NDC Code(s): 62699-3312-1, 62699-3312-2
  • Packager: Nan Mei Pharmaceutical Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 04/13

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  • PURPOSE

    Topical Analgesic

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  • Active Ingredients

    Menthol 3% - Topical Analgesic, Wintergreen Oil 0.5% - Topical Analgesic

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  • Indications

    For the temporary relief of minor aches of muscles and joints associated with:

    • simple backache
    • arthritis
    • strains
    • bruises
    • sprains
    • menstrual pain
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  • Directions

    For adults and children 6 and older. Clean the affected area before use. Can be cut to size. Peel off film and cover affected area with patch. For menstrual pain, place on abdomen. Keep on for up to 8 hours under normal conditions. Apply once or twice per day as needed. Allow skin to breath for a few hours between applications. Users with sensitive skin should test on a small area first.

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  • Warnings

    • FOR EXTERNAL USE ONLY

    • Avoid contact with eyes or mucous membranes.
    • Do not apply to wounds or damaged or irritated skin.
    • Do not use if skin is sensitive, or have allergies to any ingredients in this product. Discontinue use and consult a doctor if signs of irritation or rash appear.
    • Avoid use on extremely hairy areas of the body as removal may remove hair.

    • If pregnant or breast feeding consult a doctor before use.

    • Keep out of reach of children.
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  • Other Ingredients

    Sesame oil, resin, paeoniae veitchii radix, zinc oxide, drynariae rhizoma, angelica sinensis radix, carthami flos, pyritum, draconis resina, frankencense, myrrha, terebinthina, ligustiei rhizoma, achyranthis radix, acanthopanacus cortex, acori rhizoma, atractylodis rhizoma, tourmaline, saussureae radix, gentianae macrophyllae radix, cnidii monnieri fructus, cinnamonomi cortex, aconiti tuber, pinelliae tuber, dendrobii caulis, dioscoreae tokoro rhizoma, indigo carmine, tartrazine.

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  • For Questions or Comments Call:

    1 (800) 798-3977

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  • PAIN Terminator pouch for 5 patches.
  • INGREDIENTS AND APPEARANCE
    PAIN TERMINATOR ANALGESIC 
    topical analgesic patch
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:62699-3312
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (MENTHOL) MENTHOL .03 g  in 1 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE .005 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    SESAME OIL .471 g  in 1 g
    PINUS MASSONIANA RESIN .15 g  in 1 g
    PAEONIA VEITCHII ROOT .04 g  in 1 g
    ZINC OXIDE .03 g  in 1 g
    DRYNARIA FORTUNEI ROOT .02 g  in 1 g
    ANGELICA SINENSIS ROOT .02 g  in 1 g
    CARTHAMUS TINCTORIUS FLOWER BUD .02 g  in 1 g
    PYRITIDIUM .02 g  in 1 g
    DAEMONOROPS DRACO RESIN .02 g  in 1 g
    FRANKINCENSE .02 g  in 1 g
    MYRRH .02 g  in 1 g
    LARIX DECIDUA RESIN .02 g  in 1 g
    LIGUSTICUM SINENSE ROOT .016 g  in 1 g
    ACHYRANTHES BIDENTATA ROOT .01 g  in 1 g
    ELEUTHEROCOCCUS NODIFLORUS ROOT BARK .01 g  in 1 g
    ACORUS CALAMUS ROOT .01 g  in 1 g
    ATRACTYLODES JAPONICA ROOT .01 g  in 1 g
    SCHORL TOURMALINE .01 g  in 1 g
    SAUSSUREA COSTUS ROOT .006 g  in 1 g
    GENTIANA MACROPHYLLA ROOT .006 g  in 1 g
    CNIDIUM OFFICINALE ROOT .006 g  in 1 g
    CHINESE CINNAMON .006 g  in 1 g
    ACONITUM CARMICHAELII ROOT .006 g  in 1 g
    PINELLIA TERNATA ROOT .006 g  in 1 g
    DENDROBIUM NOBILE STEM .006 g  in 1 g
    TOKORO YAM .006 g  in 1 g
    FD&C BLUE NO. 2 .0001 g  in 1 g
    FD&C YELLOW NO. 5 .0001 g  in 1 g
    Product Characteristics
    Color brown Score     
    Shape RECTANGLE Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:62699-3312-1 50 in 1 BOX
    1 5 in 1 POUCH
    1 3 g in 1 PATCH
    2 NDC:62699-3312-2 10 in 1 BAG
    2 3 g in 1 PATCH
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 05/18/2006
    Labeler - Nan Mei Pharmaceutical Co., Ltd. (656348505)
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