EXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [ASCLEMED USA, INC.]

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EXOTEN-C (METHYL SALICYLATE, MENTHOL, CAPSAICIN) LOTION [ASCLEMED USA, INC.]
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NDC 76420-947-01
Set ID 76ed37e0-64b5-4abe-a03c-3dc7084a3919
Category HUMAN OTC DRUG LABEL
Packager Asclemed USA, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
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  • Active Ingredients

    Methyl Salicylate 20.000%

    Menthol 10.00%

    Capsaicin 0.025%

  • Purpose

    Topical Analgesic

    Topical Analgesic

    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.

    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

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice; Aqua (Deionized Water); Arnica Montana Flower Extract; Carbomer, Cetearyl Alcohol, Ethylexyl Palmitate, Glyceryl Stearate, Methylisothiazolinone, PEG-100 Stearate, Tocopheryl Acetate (Vitamin E), Triethanolamine.

  • Principal Display Panel - Exoten-C Label

    Exoten-C

    Pain Relief 
Lotion

    113.4 g

    Distributed by Enovachem™

    PHARMACEUTICALS

    Torrance, CA 90501

    (310) 320-0100

    Principal Display Panel - Exoten-C Label
  • INGREDIENTS AND APPEARANCE
    EXOTEN-C 
    methyl salicylate, menthol, capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-947
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE20 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76420-947-01113.4 g in 1 BOTTLE; Type 0: Not a Combination Product02/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34802/10/2017
    Labeler - Asclemed USA, Inc. (059888437)
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