OMEZA SKIN PROTECTANT GEL- cod liver oil gel 
Omeza LLC

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.

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Omeza Skin Protectant Gel 06 January 2023

Uses

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

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

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)

Revised: 1/2023
Document Id: f2697b08-0866-1d5d-e053-2a95a90a3e95
Set id: f18a3bca-f047-4916-e053-2995a90a7337
Version: 2
Effective Time: 20230116
 
Omeza LLC