Label: PAINPATROL PROFESSIONAL PAIN RELIEF- menthol, unspecified form gel

  • 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 February 19, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Natural Menthol, USP (8.5%)

  • Purpose

    Topical Analgesic

  • Uses

    Temporarily relieves foot, ankle and leg pain associated with:

    • arthritis
    • muscle aches
    • muscle strains
    • muscle sprains
    • joint pain
  • Warnings

    For external use only: Flammable: Keep away from excessive heat or open flame.

    • Ask a doctor before use is you have sensitive skin or if you are taking any blood thinners,

    When using this product

    Do not use on wounds or irritated skin

    • Do not bandage tightly or usewith a heating pad
    • Wash hands after use with cool water

    • If pregnant or breast feeding, ask a health professional before use

    • Keep out of reach of children. If accidentally swallowed,contact a doctor or poison control center immediately

    • Stop use and ask a doctor if condition worsens or if pain persists for more than 7 days, or clears up, then reoccurs within a few days.
  • Directions

    Use only as directed

    • Do not use on children under 12 years of age.
    • Roll onto affected area no more than four times daily. Shake well before each use.
  • Inactive Ingredients

    Aloe Barbadensis Leaf Extract, Arnica Montana Extract, Boswellia Serrata Extract, Camphor, Carbomer, Chondroitin Sulfate, Glucosamine Sulfate, Glycerin, Ilex Paraguarensis Extract, Isopropyl Alcohol, Methyl Paraben, Methylsulfonylmethane, Peppermint Oil, Polysorbate 20, Propylene Glycol, Triethanolamine, Purified Water

  • Other Information

    Questions or comments?

    Call (877) 383-2334.

    Store in a cool dry place with the cap tightly closed. Note: Because this product contains natural ingredients, color may vary.

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    SmartScience Laboratories, Inc
    13760 Reptron Blvd., Tampa, FL 33626

  • PRINCIPAL DISPLAY PANEL - 88 ML Bottle Label

    Clinical Strength Menthol Formula

    PainPatrol™
    Professional Pain Relief

    Pain Relief for arthritis, joints and muscles.
    Also contains Glucosamine • Chondroitin • Arnica • Boswellia

    No Mess Applicator.
    3FL OZ (88ML)

    Principal Display Panel - 88 ML Bottle Label
  • INGREDIENTS AND APPEARANCE
    PAINPATROL PROFESSIONAL PAIN RELIEF 
    menthol, unspecified form gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64479-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Menthol, Unspecified Form (UNII: L7T10EIP3A) (Menthol, Unspecified Form - UNII:L7T10EIP3A) Menthol, Unspecified Form85 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    CHONDROITIN SULFATE (SHARK) (UNII: 2ZAJ1K50XH)  
    GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64479-200-1088 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product03/10/2019
    2NDC:64479-200-12944 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product02/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34803/10/2019
    Labeler - SmartScience Laboratories, Inc. (035907919)
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