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

  • NDC Code(s): 53225-1022-1, 53225-1022-2, 53225-1022-3, 53225-1022-4
  • Packager: Terrain Pharmaceuticals
  • 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 26, 2021

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

  • SPL UNCLASSIFIED SECTION

  • SPL UNCLASSIFIED SECTION

    Methemoglobinemia

    Cases of methemoglobinemia have been reported in association with local anesthetic use. Although all patients are at risk for methemoglobinemia, patients with glucose-6-phosphate dehydrogenase deficiency, congenital or idiopathic methemoglobinemia, cardiac or pulmonary compromise, infants under 6 months of age, and concurrent exposure to oxidizing agents or their metabolites are more susceptible to developing clinical manifestations of the condition. If local anesthetics must be used in these patients, close monitoring for symptoms and signs of methemoglobinemia is recommended.

    Signs and symptoms of methemoglobinemia may occur immediately or may be delayed some hours after exposure and are characterized by a cyanotic skin discoloration and abnormal coloration of the blood. Methemoglobin levels may continue to rise; therefore, immediate treatment is required to avert more serious central nervous system and cardiovascular adverse effects, including seizures, coma, arrhythmias, and death. Discontinue lidocaine-containing products and any other oxidizing agents. Depending on the severity of the symptoms, patients may respond to supportive care, i.e., oxygen therapy, hydration. More severe symptoms may require treatment with methylene blue, exchange transfusion, or hyperbaric oxygen.

  • 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

    LidoproNDC 53225-1022-1

    Professional Use Only

    LidoPro

    Topical Pain Relief
    Ointment & Applicator

    Hands-Free Applicator

    Reduced Scent

    Deep Penetrating
    Long Lasting
    Soothing

    Net WT 4 oz. (121 g)

  • INGREDIENTS AND APPEARANCE
    LIDOPRO 
    capsaicin, lidocaine, menthol, and methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)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:53225-1022-1121 g in 1 BOTTLE; Type 0: Not a Combination Product01/01/2014
    2NDC:53225-1022-3300 in 1 CARTON01/01/2014
    2NDC:53225-1022-22.5 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:53225-1022-426 g in 1 TUBE; Type 0: Not a Combination Product01/01/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/01/2014
    Labeler - Terrain Pharmaceuticals (078358750)