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