Label: NEW TEROCIN- methyl salicylate, capsaicin, and menthol 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 August 18, 2022

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  • Active ingredients:

    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.

  • 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:

    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.

  • Package/Label Principal Display Panel

    NDC 50488-1129-1

    New Terocin

    Topical Pain
    Relief Lotion

    Long Lasting
    Soothing Effect

    120 ml (4 fl oz.)

     

    Manufactured for: Alexso Inc.
    Los Angeles, CA 90064

    Store in a dry, cool place

    Made in U.S.A.
    Patent Pending

    For Comments or Questions,
    call 888-495-6075

    image-01

    Label

  • INGREDIENTS AND APPEARANCE
    NEW TEROCIN 
    methyl salicylate, capsaicin, and menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50488-1129-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product03/13/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34803/13/2013
    Labeler - Alexso Inc. (963338061)
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