Label: XOTEN-C- methyl salicylate, menthol, capsaicin lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated July 26, 2011

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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 – Bottle Label

    64038-094401

    XOTEN-C

    Pain Relief
    Lotion

    Beneficial for relieving
    muscle pain and swelling

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

    Principal Display Panel – Bottle Label
  • INGREDIENTS AND APPEARANCE
    XOTEN-C 
    methyl salicylate, menthol, capsaicin lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64038-944
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Methyl salicylate (UNII: LAV5U5022Y) (Methyl salicylate - UNII:LAV5U5022Y) 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:64038-944-01113.4 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/01/2011
    Labeler - Living Well Pharmacy Inc. (070488957)
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