Label: TEROCIN- methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion

  • Category: HUMAN OTC DRUG LABEL

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Drug Label Information

Updated October 1, 2010

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  • Active ingredient

    Methyl Salicylate 25%

    Capsaicin 0.025%

    Menthol 10%

    Lidocaine 2.50%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves mild aches and pains of muscles or joints.

  • Warnings

    • Only for external use.
    • on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes. Do not use:
    • if pain is persistent or worsens or if using any other topical pain products. Consult your physician:
    • Call poison control if swallowed. If contact with the eyes occurs, rinse eyes thoroughly with cold water.
  • Keep out of reach of children.

    Consult physician for children under 12.

  • Directions

    Wash and dry affected area. Shake bottle well before each use and gently rub

    over area of pain. Use is not recommended more than four times a day. Wash

    hands immediately afterwards to avoid contact with eyes.

  • Inactive ingredients

    Water (Aqua), Propylene Glycol, Cetyl Alcohol, Stearic Acid, Glyceryl Stearate,

    PEG-100 Stearate, Dimethyl Sulfone, Aloe Barbadensis Leaf Extract, Borago

    Officinalis Seed Oil, Boswellia Serrata Extract, Xanthan Gum, Triethanolamine,

    Methylparaben, Propylparaben, DMDM Hydantoin, Iodopropynyl Butylcarbamate.

  • TEROCIN (METHYL SALICYLATE, CAPSAICIN, MENTHOL AND LIDOCAINE HYDROCHLORIDE) LOTION

    Label Image
  • INGREDIENTS AND APPEARANCE
    TEROCIN 
    methyl salicylate, capsaicin, menthol and lidocaine hydrochloride lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50436-9995(NDC:50488-1231)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE25 g  in 100 mL
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.025 g  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE2.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORAGE OIL (UNII: F8XAG1755S)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50436-9995-1120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2010
    Labeler - Unit Dose Services (831995316)
    Registrant - Unit Dose Services (831995316)
    Establishment
    NameAddressID/FEIBusiness Operations
    Unit Dose Services831995316REPACK(50436-9995)