Label: OMEZA LIDOCAINE LAVAGE- lidocaine oil

  • 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 September 22, 2022

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  • Drug Facts

  • Active ingredients

    Lidocaine 0.8%

    Purpose

    pain relieving

  • Use

    for the temporary relief of pain and itching.

  • Warnings

    For external use only

    When using this product

    • Avoid contact with eyes.

    Do not use

    • in large quantities, particularly over raw surfaces or blistered areas.

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years and older. Apply to affected area not more than 3 to 4 times daily.
    Children under 2 years of age: Consult a doctor.

  • Inactive ingredients

    caprylic/capric triglyceride, caprylic fatty acid, cetyl palmitate, cod liver oil, glyceryl monolaurate, hempseed oil, palm oil

  • Questions or Comments

    1-888-886-6392

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    OMEZA LIDOCAINE LAVAGE 
    lidocaine oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73033-002
    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 PALMITATE (UNII: 5ZA2S6B08X)  
    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:73033-002-0010 in 1 BOX12/01/2021
    11 in 1 POUCH
    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 not finalpart34812/01/2021
    Labeler - Omeza LLC (118802035)
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