Label: PAIN TERMINATOR ANALGESIC- topical analgesic cream

  • NDC Code(s): 67475-313-01, 67475-313-02, 67475-313-03
  • 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

If you are a consumer or patient please visit this version.

  • PURPOSE

    Topical Analgesic

  • Active Ingredients

    Menthol 2% - 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
  • Directions

    Apply to affected area not more than 2 to 3 times daily. Try on small area first to test for
    sensitivity. Children under 4 years of age should not use, unless consulted by a physician.

  • Warnings

    • FOR EXTERNAL USE ONLY

    • Avoid contac 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.
    • In case of ingestion, seek professional assistance or contact a Poison Control Center immediately.

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

    • Keep out of reach of children.
  • Other Ingredients

    Jojoba oil, paeonia veitchii radix, angelicae sinensis radix, carthami flos, pyritum, draconis resina, myrrha, ligustici rhizoma, acanthopanacis cortex, achyranthis radix, atractylodis rhizoma, gentianae macrophyllae radix, pinelliae tuber, saussureae radix, cnidii monnieri fructus, cinnamonomi cortex, dioscoreae tokoro rhizoma, jasmine oil, tourmaline

  • For Questions or Comments Call:

    1 (800) 798-3977

  • PAIN Terminator sleeve for 50g tube.

    PT Cream Sleeve for 50g Tube.jpg

  • INGREDIENTS AND APPEARANCE
    PAIN TERMINATOR ANALGESIC 
    topical analgesic cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67475-313
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL.02 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE.005 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    JOJOBA OIL (UNII: 724GKU717M) .75 g  in 1 g
    PAEONIA VEITCHII ROOT (UNII: VX6GD6M93V) .04 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
    MYRRH (UNII: JC71GJ1F3L) .02 g  in 1 g
    LIGUSTICUM SINENSE ROOT (UNII: 32SLT970XO) .015 g  in 1 g
    ELEUTHEROCOCCUS NODIFLORUS ROOT BARK (UNII: W7PRK433YB) .1 g  in 1 g
    ACHYRANTHES BIDENTATA ROOT (UNII: 5QIU26R6P1) .01 g  in 1 g
    ATRACTYLODES JAPONICA ROOT (UNII: 58N5X5H9XU) .01 g  in 1 g
    GENTIANA MACROPHYLLA ROOT (UNII: 6559FC0U1B) .006 g  in 1 g
    PINELLIA TERNATA ROOT (UNII: G9AET085M5) .006 g  in 1 g
    SAUSSUREA COSTUS ROOT (UNII: RUP970CGR9) .006 g  in 1 g
    CNIDIUM MONNIERI FRUIT (UNII: V1IA3S3CUS) .006 g  in 1 g
    CHINESE CINNAMON (UNII: WS4CQ062KM) .005 g  in 1 g
    DIOSCOREA JAPONICA TUBER (UNII: I43FCF3356) .005 g  in 1 g
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432) .003 g  in 1 g
    SCHORL TOURMALINE (UNII: 173O8XLY6T) .003 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
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67475-313-01500 g in 1 JAR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)02/23/2009
    2NDC:67475-313-0212 in 1 BOX02/23/2009
    21 in 1 BOX
    250 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
    3NDC:67475-313-035 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)02/23/2009
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/23/2009
    Labeler - Golden Sunshine International, Inc. (098930857)
    Registrant - Golden Sunshine International, Inc. <paragraph/></text> (098930857)
    Establishment
    NameAddressID/FEIBusiness Operations
    Golden Sunshine International, Inc. <paragraph/></text>098930857label(67475-313)