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

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

Drug Label Information

Updated December 31, 2024

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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.

    Keep out of reach of children.

    Consult physician for children under 12.

  • 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.

  • DOSAGE & ADMINISTRATION

    As directed

  • INDICATIONS & USAGE

    Consult your physician

  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Borago Officinalis (Borage) Seed Oil, Boswellia Serrata Extract, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Cetyl Alcohol, Diazolidinyl Urea, Dimethyl Sulfone (DMSO), DMDM Hydantoin, Glyceryl Stearate, Lavandula Angustifolia (Lavender) Oil, Methyl Paraben, PEG-100 Stearate, Polysorbate-20, Polysorbate-60, Propyl Paraben, Propylene Glycol, Stearic Acid, Stearyl Alcohol, Triethanolamine, Xanthan Gum.

  • HOW SUPPLIED

    Bottle of:

    120ml NDC: 80425-0256-01

  • PRINCIPAL DISPLAY PANEL

    label 1

  • INGREDIENTS AND APPEARANCE
    NEW TEROCIN 
    methyl salicylate, capsaicin, and menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0256(NDC:50488-1129)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 mL
    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
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0256-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product02/15/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01702/15/2023
    Labeler - Advanced Rx Pharmacy of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx Pharmacy of Tennessee, LLC117023142repack(80425-0256)
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