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

  • NDC Code(s): 53225-1020-1
  • Packager: Terrain Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 16, 2023

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  • SPL UNCLASSIFIED SECTION

  • Active Ingredient

    Capsaicin 0.0325%

  • Purpose

    Counterirritant

  • Active Ingredient

    Lidocaine HCL 4%

  • Purpose

    Topical Anesthetic

  • Active Ingredient

    Menthol 10%

  • Purpose

    Topical Analgesic

  • Active Ingredient

    Methyl Salicylate 27.5%

  • Purpose

    Counterirritant

  • Uses

    For the temporary relief of joint pain and muscle pain associated with:

    • Arthritis
    • Simple Backache
    • Muscle Sprains
    • Muscle Strains
  • Warnings

    For External Use Only

    Do Not Use

    • On damaged, irritated, or infected skin
    • With a bandage or heating pad
    • If you are allergic to any ingredients in this product

    When Using This Product:

    Avoid contact with eyes and mucus membranes

    Stop Use and Ask a Doctor If:

    • Conditions worsens
    • Excessive skin irritation develops
    • Symptoms persist for more than 7 days, or symptoms clear up and occur again within 3 days

    If Pregnant orBreast-Feeding:

    Ask a health professional before use.

    Keep Out of Reach of Children:

    If ingested seek medical help or contact a Poison Control Center immediately

    Flammable:

    Keep away from excessive heat or open flame

  • Directions

    Adults and Children 12 Years of Age and Older:

    • Clean and dry the affected area
    • Apply product directly to your skin, up to 4 times daily affected area
    • Wash hands immediately after use

    Children Under 12 Years of Age:Consult physician

  • Other Information

    • Store in a cool, dry place with lid tightly closed
    • If the tamper-evident foil seal is not intact, do not use
  • 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.

  • Questions or Comments?

    info@terrainrx.com

  • Principal Display Panel

    NDC 53225-1020-1

    lidopro

  • INGREDIENTS AND APPEARANCE
    LIDOPRO 
    capsaicin, lidocaine, menthol, and methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53225-1020
    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
    INULIN (UNII: JOS53KRJ01)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    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)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53225-1020-192 g in 1 BOTTLE; Type 0: Not a Combination Product07/08/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/08/2022
    Labeler - Terrain Pharmaceuticals (078358750)
    Registrant - Westwood Laboratories, LLC (832280635)
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