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

  • Label RSS
  • NDC Code(s): 53225-1021-1
  • Packager: Terrain Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 12/12

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

  • Active Ingredient

    Capsaicin 0.0325%

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  • Purpose

    Topical Analgesic

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  • Active Ingredient

    Lidocaine 4.5%

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  • Purpose

    Topical Analgesic

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  • Active Ingredient

    Menthol 10%

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  • Purpose

    Topical Analgesic

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  • Active Ingredient

    Methyl Salicylate 27.5%

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  • Purpose

    Topical Analgesic

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  • Uses:

    Temporarily relieves minor aches and muscles pains associated with:

    • arthritis
    • simple back pain
    • strains
    • muscle soreness
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  • 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)

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  • 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

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  • 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
    Walnut Creek, CA 94596

    Made in the U.S.A.
    Patent Pending

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  • Principal Display Panel

    NDC 53225-1021-1
    LidoPro
    (Lidoprocin)
    Topical Pain Relief Ointment
    Deep Penetrating
    Long Lasting
    Soothing
    Net WT 4 oz. (121 g)

    NDC 53225-1021-1
LidoPro™
(Lidoprocin)
Topical Pain Relief Ointment
Deep Penetrating
Long Lasting
Soothing
Net WT 4 oz. (121 g)

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  • INGREDIENTS AND APPEARANCE
    LIDOPRO 
    capsaicin, lidocaine, menthol, and methyl salicylate ointment
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:53225-1021
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CAPSAICIN (CAPSAICIN) CAPSAICIN 0.000325 g  in 1 g
    LIDOCAINE (LIDOCAINE) LIDOCAINE 0.045 g  in 1 g
    MENTHOL (MENTHOL) MENTHOL 0.10 g  in 1 g
    METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 0.275 g  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    ALLANTOIN  
    ALOE VERA LEAF  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER  
    CETYL ALCOHOL  
    CHAMOMILE  
    DIMETHICONE  
    EDETATE DISODIUM  
    ETHYLHEXYLGLYCERIN  
    GLYCERIN  
    GLYCERYL MONOSTEARATE  
    PEG-100 STEARATE  
    TROLAMINE  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53225-1021-1 121 g in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 12/01/2012
    Labeler - Terrain Pharmaceuticals (078358750)
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