Label: NEW TEROCIN- methyl salicylate, capsaicin, and menthol lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 21, 2023

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  • Active ingredient

    Methyl Salicylate 25%

    Capsaicin 0.025%

    Menthol 10%

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves mild aches and pains of muscles or joints.

  • Warnings

    • Only for external use.
    • Do not use: on open wounds, cuts, damaged or infected skin as well as in the eyes, mouth, genitals, or any other mucous membranes.
    • Consult your physician: if pain is persistent or worsens or if using any other topical pain products.
    • 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), Cetyl Alcohol, Stearic Acid, Glyceryl Stearate, PEG-100 Stearate,

    Propylene Glycol, Dimethyl Sulfone, Lavandula Angustifolia (Lavendar) Oil,

    Lidocaine, Aloe Barbadensis Leaf Extract, Borago Officinalis Seed Oil, Boswellia

    Serrata Extract, Xanthan Gum, Triethanolamine, Methylparaben, Propylparaben,

    DMDM Hydantoin, Iodopropynyl Butylcarbamate.

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NEW TEROCIN 
    methyl salicylate, capsaicin, and menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35356-963(NDC:50488-1129)
    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
    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)  
    LIDOCAINE (UNII: 98PI200987)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    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:35356-963-11120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/13/201309/30/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01703/13/201309/30/2025
    Labeler - Quality Care Products, LLC (831276758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Quality Care Products, LLC831276758relabel(35356-963)
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