Label: LIMENCIN- methyl salicylate, capsaicin, 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 February 12, 2019

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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.

    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

    NDC 50488-1130-1

    Limencin Lotion
    Topical Pain Relief
    Long Lasting
    Soothing Effect
    120 ml (4 fl oz.)

    Manufactured for: Alexso, Inc.

    Los Angeles, CA 90064

    Store in a dry, cool place
    For Comments or Questions,
    call 888.495.6078

    Made in the U.S.A.
    Patent Pending

    PRINCIPAL DISPLAY PANEL NDC 50488-1130-1 Limencin Lotion Topical Pain Relief 120 ml (4 fl oz.)

    Label

  • INGREDIENTS AND APPEARANCE
    LIMENCIN 
    methyl salicylate, capsaicin, menthol lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50488-1130
    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)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIDOCAINE (UNII: 98PI200987)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50488-1130-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product10/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34810/01/2018
    Labeler - Alexso, Inc. (963338061)
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