OMEZA LAVAGE (LIDOCAINE) OIL [OMEZA LLC]

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OMEZA LAVAGE (LIDOCAINE) OIL [OMEZA LLC]
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NDC 73033-001-14
Set ID acd83722-0141-4831-b599-07eac95acc1e
Category HUMAN OTC DRUG LABEL
Packager Omeza LLC
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
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  • Drug Facts

  • Active Ingredient

    Lidocaine 0.8%

    Purpose

    External analgesic

  • Use

    For the temporary relief of pain

  • Warnings

    For external use only

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas
    • on puncture wounds
    • do not use if you are allergic to lidocaine or any of the inacitve ingredients listed below

    When using this product

    • use only as directed. Read and follow all directions and warnings on this carton.
    • do not allow contact with the eyes

    Stop use and ask a doctor if

    • allergic reaction occurs
    • condition worsens or if symptoms persist for more than 7 days
    • symptoms clear up and return within a few days
    • redness, irritation, swelling, pain or other symptoms begin or increase

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children 

    and pets. If swallowed, get medical help or contact a Poison Control Center immediately 

  • Directions

    Adults and children 12 years and older: Apply a thin layer to affected area every 8 to 12 hours.

    Children under 12 years: Consult a physician before use.

    Instructions for use

    • clean and dry affected area
    • snap open top of vial
    • apply a thin layer to affected area
    • discard vial with any excess or unused dose
    • wash hands thoroughly after applying
  • Other information

    • Do not use if package is damaged or open.
    • protect from freezing or excessive heat
    • store at 68°-77°F (20°-25°C).
  • Inactive ingredients

    Caprylic Fatty Acid, Caprylic/Capric Triglyceride, Cetyl Esters NF, Cod Liver Oil, Glyceryl Monolaurate, Hempseed Oil, Palm Oil

  • Questions?

    Call toll-free 888-886-6392 or visit www.omeza.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    OMEZA LAVAGE 
    lidocaine oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73033-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE8 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    COD LIVER OIL (UNII: BBL281NWFG)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    PALM OIL (UNII: 5QUO05548Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73033-001-1414 in 1 BOX04/15/2019
    12 mL in 1 VIAL; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34804/15/2019
    Labeler - Omeza LLC (057694073)
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