Label: OMEZA SKIN PROTECTANT GEL- cod liver oil gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 January 16, 2023

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  • Uses

    Uses temporarily protects and helps relieve minor skin irritation and itching due to

    • rashes
    • eczema
  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again in a few days.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions Apply as needed. No more than 2 vials per 24 hours.

  • Inactive Ingredients

    ascorbyl palmitate, caprylic/capric triglyceride, cetyl esters, coconut oil, glyceryl monolaurate, hemp seed oil, palm oil

  • Questions or Comments?

    Questions or Comments? 1-888-886-6392

  • Drug Facts

    Display Panel

    Active ingredient

    (in each vial)

    Cod Liver Oil 13.56%

    Purpose

    Skin Protectant

  • INGREDIENTS AND APPEARANCE
    OMEZA SKIN PROTECTANT GEL 
    cod liver oil gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73033-007
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COD LIVER OIL (UNII: BBL281NWFG) (COD LIVER OIL - UNII:BBL281NWFG) COD LIVER OIL14.24 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)  
    PALM OIL (UNII: 5QUO05548Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73033-007-0210 in 1 BOX11/21/2022
    11 in 1 POUCH
    12 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01611/21/2022
    Labeler - Omeza LLC (118802035)
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