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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

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.

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  • Principal Display Panel

    lidopro

  • INGREDIENTS AND APPEARANCE
    LIDOPRO 
    capsaicin, lidocaine, menthol, and methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76420-038(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:76420-038-9292 g in 1 BOTTLE; Type 0: Not a Combination Product01/07/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01707/08/2022
    Labeler - Asclemed USA, Inc. (059888437)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASCLEMED USA INC. DBA ENOVACHEM059888437relabel(76420-038)
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