Label: PAIN TERMINATOR ANALGESIC- topical analgesic patch

  • NDC Code(s): 67475-312-01, 67475-312-02
  • Packager: Golden Sunshine International, Inc.
  • 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 December 18, 2019

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  • PURPOSE

    Topical Analgesic

  • Active Ingredients

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

  • Indications

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

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

  • 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.
  • Other Ingredients

    Sesame oil, resin, paeoniae veitchii radix, zinc oxide, drynariae rhizoma, angelicae 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, cinnamomum cortex, aconiti tuber, pinelliae tuber, dendrobii caulis, dioscoreae tokoro rhizoma, indigo carmine, tartrazine.

  • For Questions or Comments Call:

    1 (800) 798-3977

  • PAIN Terminator pouch for 5 patches.

    Pouch for PAIN Terminator Patches.jpg

  • INGREDIENTS AND APPEARANCE
    PAIN TERMINATOR ANALGESIC 
    topical analgesic patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67475-312
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.03 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE.005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    SESAME OIL (UNII: QX10HYY4QV) .471 g  in 1 g
    PINUS MASSONIANA RESIN (UNII: 64S07U83T7) .15 g  in 1 g
    PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V) .04 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) .03 g  in 1 g
    DRYNARIA FORTUNEI ROOT (UNII: 731W842X8Q) .02 g  in 1 g
    ANGELICA SINENSIS ROOT (UNII: B66F4574UG) .02 g  in 1 g
    CARTHAMUS TINCTORIUS FLOWER BUD (UNII: B86IS274O0) .02 g  in 1 g
    PYRITIDIUM (UNII: 0PFV70949S) .02 g  in 1 g
    DAEMONOROPS DRACO RESIN (UNII: 787Z7N9UCU) .02 g  in 1 g
    FRANKINCENSE (UNII: R9XLF1R1WM) .02 g  in 1 g
    MYRRH (UNII: JC71GJ1F3L) .02 g  in 1 g
    LARIX DECIDUA RESIN (UNII: AD8LJ73GQF) .02 g  in 1 g
    LIGUSTICUM SINENSE ROOT (UNII: 32SLT970XO) .016 g  in 1 g
    ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1) .01 g  in 1 g
    ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB) .01 g  in 1 g
    ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F) .01 g  in 1 g
    ATRACTYLODES JAPONICA ROOT (UNII: 58N5X5H9XU) .01 g  in 1 g
    SCHORL TOURMALINE (UNII: 173O8XLY6T) .01 g  in 1 g
    SAUSSUREA COSTUS ROOT (UNII: RUP970CGR9) .006 g  in 1 g
    GENTIANA MACROPHYLLA ROOT (UNII: 6559FC0U1B) .006 g  in 1 g
    CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J) .006 g  in 1 g
    CHINESE CINNAMON (UNII: WS4CQ062KM) .006 g  in 1 g
    ACONITUM CARMICHAELII ROOT (UNII: XJ28061U1S) .006 g  in 1 g
    PINELLIA TERNATA ROOT (UNII: G9AET085M5) .006 g  in 1 g
    DENDROBIUM NOBILE STEM (UNII: CGO90PC910) .006 g  in 1 g
    TOKORO YAM (UNII: N57RVD5L6U) .006 g  in 1 g
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK) .0001 g  in 1 g
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M) .0001 g  in 1 g
    Product Characteristics
    ColorbrownScore    
    ShapeRECTANGLESize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67475-312-0150 in 1 BOX05/18/2006
    15 in 1 POUCH
    13 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    2NDC:67475-312-0210 in 1 BAG05/18/2006
    23 g in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/18/2006
    Labeler - Golden Sunshine International, Inc. (098930857)
    Registrant - Golden Sunshine International, Inc. (098930857)
    Establishment
    NameAddressID/FEIBusiness Operations
    Golden Sunshine International, Inc.098930857label(67475-312)
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