Label: LIDOPRO PAIN RELIEF- capsaicin and lidocaine ointment

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

Drug Label Information

Updated January 15, 2025

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  • Active ingredient

    • Capsicum annum fruit extract (capsaicin)
    • Lidocaine HCL
    • Menthol
    • Methyl Salicylate
  • Purpose

    • counterirritant
    • anesthetic
    • analgesic
  • 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 the eyes and mucous membranes

    Stop use and ask doctor if

    • condition worsens
    • excessive skin
    • irritation develops
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within 3 days

    If pregnant or breast-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 skin, up to 4 times daily
    • 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 ingredient

    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?

    (800) 224-2048 or info@clinicpharma.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Lidopro Ointment #99

  • INGREDIENTS AND APPEARANCE
    LIDOPRO PAIN RELIEF 
    capsaicin and lidocaine ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80425-0452(NDC:83881-001)
    Route of AdministrationTRANSDERMAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL, (+)- (UNII: C6B1OE8P3W) (MENTHOL, (+)- - UNII:C6B1OE8P3W) MENTHOL, (+)-10 mg  in 100 mg
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS4 mg  in 100 mg
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE27.5 mg  in 100 mg
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.0325 mg  in 100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)  
    TRIETHANOLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    INULIN LAURYL CARBAMATE (UNII: 48RFF58ESG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80425-0452-11 in 1 BOX11/26/2024
    19900 mg in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01711/26/2024
    Labeler - Advanced Rx of Tennessee, LLC (117023142)
    Establishment
    NameAddressID/FEIBusiness Operations
    Advanced Rx of Tennessee, LLC117023142repack(80425-0452)
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