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KINeSYS (KINeSYS Pharmaceutical Inc.)

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STICK 50 g in 1 CYLINDER (61481-0020-1) Label Information

Complete KINeSYS Information

  • RECOMMENDED USE

    Temporarily relieves aches and pains of muscles and joints associated with one or more of the following: backache, strains and sprains (involving muscles, tendons, and/or ligaments), and arthritis.


  • DURATION OF USE

    Consult a health care practitioner for use beyond 7 days.


  • STORAGE AND HANDLING

    • Store protected from direct light and moisture at room temperature.

  • MEDICINAL INGREDIENTS (PER DOSE UNIT)

    Methyl salicylate 30%, Menthol (l-Menthol, Mentha arvensis - Herb top) 15%.


  • NON-MEDICINAL INGREDIENTS

    Propylene glycol, PEG-8, Ethyl alcohol, Sodium stearate, Aqua, D&C Green No. 5.


  • RECOMMENDED DOSE

    Adults, adolescents

    1-4 time(s) per day. Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until solution vanishes. For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.

    Children 2-12 years old

    1-4 time(s) per day. Application should be supervised by an adult. Apply thinly and evenly to affected area up to 3 to 4 times per day. Rub and/or massage into skin until solution vanishes. For external use only. Avoid contact with the eyes and mucous membranes. Do not apply to wounds or damaged skin. Do not tightly bandage. Do not apply with external heat, such as an electric heating pad, as this may result in excessive skin irritation or skin burn.


  • CAUTIONS AND WARNINGS

    Keep out of the reach of children.

    If overdose or accidental ingestion occurs, call a Poison Control Center immediately.

    Discontinue use and consult a health care practitioner if symptoms persist and/or worsen after 7 days or re-occur within a few days.

    Consult a healthcare practitioner prior to use if you are pregnant or breastfeeding .

    Consult a healthcare practitioner prior to use if you are taking anticoagulant medications.

    Store protected from direct light and moisture at room temperature.


  • KNOWN ADVERSE REACTIONS

    Rashes and/or burning discomfort have been known to occur; in which case, discontinue use. Hypersensitivity such as allergy has been known to occur; in which case, discontinue use.


  • PRINCIPAL DISPLAY PANEL - 50 g Cylinder Label

    KINeSYS®

    Analgesic
    SPORT STICK

    • penetrating warm PAIN RELIEF
      for muscular and arthritic discomfort

    extra strength MUSCLE CARE

    Topical

    Hands-free applicator

    50 g (1.76 OZ)

    NPN 80029329

    Principal Display Panel - 50 g Cylinder Label

  • INGREDIENTS AND APPEARANCE
    KINESYS  ANALGESIC SPORT
    methyl salicylate and menthol stick
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61481-0020
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 30 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 15 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM STEARATE (UNII: QU7E2XA9TG)  
    WATER (UNII: 059QF0KO0R)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61481-0020-1 50 g in 1 CYLINDER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 05/31/2012
    Labeler - KINeSYS Pharmaceutical Inc. (252292719)