KINESYS ANALGESIC SPORT (METHYL SALICYLATE AND MENTHOL) STICK [KINESYS PHARMACEUTICAL INC.]

KINESYS ANALGESIC SPORT (METHYL SALICYLATE AND MENTHOL) STICK [KINESYS PHARMACEUTICAL INC.]
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NDC 61481-0020-1
Set ID c1d58e0c-a66d-48d0-b1c3-cb0546595b42
Category HUMAN OTC DRUG LABEL
Packager Wilc Healthcare Inc
Generic Name
Product Class
Product Number
Application Number PART348
  • 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:61481-0020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE30 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61481-0020-150 g in 1 CYLINDER; Type 0: Not a Combination Product05/31/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34805/31/2012
    Labeler - Wilc Healthcare Inc (203499140)
    Registrant - Wilc Healthcare Inc (203499140)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmaceutical Research Laboratory Inc256797309manufacture(61481-0020)

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