Label: LIDOPRO- capsaicin, lidocaine, menthol, and methyl salicylate ointment

  • 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 April 16, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    Capsaicin 0.0325%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Lidocaine HCL 4%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Menthol 10%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Methyl Salicylate 27.5%

  • Purpose

    Topical Analgesic

  • Uses:

    Temporarily relieves minor aches and muscles pains associated with:

    • arthritis
    • simple back pain
    • strains
    • muscle soreness
  • Warnings

    For external use only

    Do not use

    • on open wounds, cuts, damaged or infected skin
    • with bandage or a heating pad
    • if condition worsens or symptoms persists for more than 7 days
    • excessive skin irritation occurs

    Ask a doctor before use if

    • you are allergic to any ingredients, PABA, aspirin products or sulfa

    When using this product

    • avoid contact with eyes, genitals, and other mucus membranes. If eye contact occurs, rinse thoroughly with water.

    If pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away. Package not child resistant.

    Store

    at 20C - 25C (68F - 77F)

  • Directions

    Adults 18 years and children 12 years and older:

    • apply product directly to affected area
    • product may be used as necessary, but should not be used more than four times per day.
    • wash hands immediately afterwards

    Children 12 years or younger: ask a doctor

  • Inactive Ingredients

    Allantoin, Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Cetyl Alcohol, Chamomilla Recutita Matricaria Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Inulin Lauryl Carbamate, PEG-100 Stearate, Phenoxyethanol, Stearic Acid, Triethanolamine, Water.

    For Questions or Comments

    Please Email info@TerrainRX.com

    Manufactured for
    Terrain Pharmaceuticals
    Reno, NV 89501

    Made in the U.S.A.
    Patent Pending

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    LIDOPRO 
    capsaicin, lidocaine, menthol, and methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55700-523(NDC:53225-1022)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.000325 g  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.04 g  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.1 g  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE0.275 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55700-523-01121 g in 1 BOTTLE; Type 0: Not a Combination Product05/19/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2014
    Labeler - Lake Erie Medical DBA Quality Care Products LLC (831276758)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lake Erie Medical DBA Quality Care Products LLC831276758relabel(55700-523)