KELVIN PRO PAIN RELIEF ROLL ON (METHYL SALICYLATE, AMOMUM TESTACEUM SEED) LIQUID [US COSMETICS, INC]

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KELVIN PRO PAIN RELIEF ROLL ON (METHYL SALICYLATE, AMOMUM TESTACEUM SEED) LIQUID [US COSMETICS, INC]
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NDC 72569-760-03
Set ID 9cb6dfd1-c655-46dc-b4d4-5c2b8a2e42aa
Category HUMAN OTC DRUG LABEL
Packager US Cosmetics, Inc
Generic Name
Product Class
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredient:

    Methyl Salicylate 12%

    Camphor 3%

    Purpose:

    Topical Analgesic

  • Indications:

    For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains.

  • Warnings:

    • For external use only.
    • Avoid contact with eyes.

    Do not apply

    • to open wounds or damaged skin.
    • If symptoms persist for more than seven days, discontinue use and consult physician.

    Keep out of reach of children.

    • If swallowed, consult physician.
    • Do not apply to wounds or damaged skin.
    • Do not bandage tightly.

    If pregnant or breast feeding,

    contact physician prior to use.

  • Directions:

    • Adults and children two-years of age or older: Apply to affected area not more than three to four times daily.
    • Children under two-years of age: consult a physician.
  • Additional Information:

    Store at room temperature.

  • Other Ingredients:

    Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Ethylhexylglycerin, Helianthus Annuus (Sunflower) Oil, Isopropyl Myristate, Magnesium Sulfate, Phenoxyethanol, Sodium Lauryl Sulfate, Triethanolamine.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    KELVIN PRO PAIN RELIEF ROLL ON 
    methyl salicylate, amomum testaceum seed liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72569-760
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE120 mg  in 1 mL
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72569-760-0389 mL in 1 BOTTLE; Type 0: Not a Combination Product09/10/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/10/2018
    Labeler - US Cosmetics, Inc (081369740)
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