LUBRACANE GEL [OZEION LLC]

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LUBRACANE GEL [OZEION LLC]
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NDC 72235-5838-1
Set ID 7c503e3e-1987-4027-8a43-12acf2cb548a
Category HUMAN OTC DRUG LABEL
Packager Ozeion LLC
Generic Name
Product Class
Product Number
Application Number PART341
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  • Active Ingredients

    Menthol 0.24% Topical Analgesic

  • INDICATIONS & USAGE

    Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with arthritis and minor injuries including sprains, strains and bruises.

  • WARNINGS

    Warnings

    For external use only. Avoid contact with eyes and open wounds. Do not use if allergic to any of its ingredients.

    ​Keep out of reach of children.​ If swallowed, get medical help or contact Poison Control immediately.

  • Do Not Use

    If pregnant, breast feeding or intending to become pregnant.

  • Precautions

    Stop use and consult a physician if pain persists beyond 3 days, a rash or irritation develops, or if condition worsens, or resolves and then returns. 

  • Directions

    Adults and Children over 12. Apply an adequate amount of gel to cover affected area. On day 1 apply 2 to 3 times within the first hour, and up to six times that day. On the following days, apply 3 to 4 times a day, as needed. 

  • Inactive Ingredients

    Filtrated deionized water, MethylSulfonylMethane (MSM), Acrylates/C-10-30, Alkyl Acrylate Crosspolymer, Polysorbate-20, Propylene Glycol (and) Dizolidinyl Urea (and) Iodopropynyl Butylcarbamate, Ammonium Hydroxide. 

  • Other Information

    Store between 68° and 74°F (20°-23°C) with closed cover. Do not apply with hot pack. 

  • Questions or Comments

    Email us at: info@lubracane.com

  • Label 

    label

    image description

  • INGREDIENTS AND APPEARANCE
    LUBRACANE 
    lubracane gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72235-5838
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.24 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    AMMONIA (UNII: 5138Q19F1X)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72235-5838-1118.3 mL in 1 JAR; Type 0: Not a Combination Product01/15/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34101/15/2018
    Labeler - Ozeion LLC (067331308)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ozeion LLC067331308manufacture(72235-5838)
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