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 76420-944-01
Set ID 7c9f2e53-332e-4c48-83c2-8444d1afa8d3
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%

    Menthol USP 10%

    Capsaicin 0.002%

  • Purpose

    Topical analgesic

  • Use

    For the temporary relief of minor aches and pains of muscles and joints associated with:

    • simple backache
    • arthritis
    • sprains
    • strains
    • bruises
  • Warnings

    For external use only.

    Do not use

    • on wounds
    • damaged, broken, or irritated skin
    • with a heating pad
    • immediately before or after taking a bath or shower

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • skin irritation occurs

    When using this product

    • avoid contact with lips, eyes, nose and any mucous membranes at all times
    • do not bandage tightly

    Keep out of reach of children.

    If swallowed get medical help or contact Poison Control Center right away.

  • Directions

    • use only as directed
    • Wash hands thoroughly after use to avoid spreading lotion to the eyes or other sensitive areas of the body
    • if applying lotion to the hands, wait 30 minutes before washing hands
    • Adults and children 12 years of age and older:
      • apply to affected area not more than 3-4 times daily
    • Children under 12 years of age:
      • do not use
      • consult a doctor
  • Other information

    • Store at room temperature
  • Inactive ingredients

    D.I. Water, Ethylhexyl Palmitate, Cetearyl Alcohol, Glycerin, Arnica Extract, Aloe Babadensis (Aloe Vera) Leaf Extract, Vitamin E Acetate, Carbomer, Triethanolamine, Phenoxyethanol and Methyldibrome Glutaronitrile

  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL DISPLAY PANEL – BOTTLE LABEL

    76420-944-01

    EXOTEN-C

    Pain Relief
    Lotion

    Beneficial for relieving
    muscle pain and swelling

    Manufactured for: Net Wt. 4 oz
    Enovachem Pharmaceuticals (113.4 g)
    Torrance, CA 90501

    310-320-0100

    PRINCIPAL DISPLAY PANEL – BOTTLE LABEL
  • INGREDIENTS AND APPEARANCE
    EXOTEN-C 
    methyl salicylate, menthol, capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-944
    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) Capsaicin0.002 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    Glycerin (UNII: PDC6A3C0OX)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    METHYLDIBROMO GLUTARONITRILE (UNII: YX089CPS05)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76420-944-01113.4 g in 1 BOTTLE; Type 0: Not a Combination Product05/08/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/08/2012
    Labeler - Asclemed USA, Inc. (059888437)
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