Label: LIDOPRO 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 25, 2019

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

  • ACTIVE INGREDIENT


    Capsaicin 0.0325%

  • PURPOSE


    Lidocaine HCL 4%

  • ACTIVE INGREDIENT


    Lidocaine HCL 4%

  • ACTIVE INGREDIENT


    Menthol 10%

  • ACTIVE INGREDIENT


    Methyl Salicylate 27.5%

  • INDICATIONS & USAGE

    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 20○C - 25○C (68○F - 77○F)

  • DOSAGE & ADMINISTRATION

    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 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.

    For Questions or Comments

    Please Email info@TerrainRX.com

    Manufactured for
    Terrain Pharmaceuticals
    Reno, NV 89501

    Made in the U.S.A.
    Patent Pending

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • PRINCIPAL DISPLAY PANEL

    577-04

  • INGREDIENTS AND APPEARANCE
    LIDOPRO 
    lidopro ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61919-577(NDC:53225-1022)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.04 g  in 1 g
    CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN0.000325 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
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CHAMOMILE (UNII: FGL3685T2X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61919-577-04121 g in 1 BOTTLE; Type 0: Not a Combination Product04/25/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34804/25/2019
    Labeler - DirectRX (079254320)
    Registrant - DirectRX (079254320)
    Establishment
    NameAddressID/FEIBusiness Operations
    DirectRX079254320relabel(61919-577)