FDA.reportPublic FDA data

Omeza Skin Protectant Gel

Manufacturer
Omeza LLC
Effective date
2023-01-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:23

Label at a glance#

ProductOmeza Skin Protectant Gel
Active ingredientCOD LIVER OIL
Label structure6 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Uses

INDICATIONS & USAGE SECTION

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

  • rashes
  • eczema

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • avoid contact with eyes.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

Questions or Comments? 1-888-886-6392

Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Display PanelDisplay Panel

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

(in each vial)

Cod Liver Oil 13.56%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73033-007-022024-07-30C16284748780-11030e365-1437-111a-e063-dadaa90a10e2Omeza Skin Protectant Gel 06 January 2023
73033-007-022024-01-30C16284748780-11030e365-1437-111a-e063-dadaa90a10e2Omeza Skin Protectant Gel 06 January 2023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73033-007-02Omeza Skin Protectant Gel10 in 1 BOXGEL102
73033-007-02Omeza Skin Protectant Gel1 in 1 POUCHGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73033-007OMEZA SKIN PROTECTANT GEL (COD LIVER OIL) GEL [OMEZA LLC]22 package rows20230120_f18a3bca-f047-4916-e053-2995a90a7337.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73033-00773033-007-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
COD LIVER OILBBL281NWFGACTIB
ASCORBYL PALMITATEQN83US2B0NIACT
CETYL ESTERS WAXD072FFP9GUIACT
GLYCERYL LAURATEY98611C087IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
PALM OIL5QUO05548ZIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
f2697b08-0866-1d5d-e053-2a95a90a3e95f18a3bca-f047-4916-e053-2995a90a73372023-01-16WarningsExact identifier
spl id: f2697b08-0866-1d5d-e053-2a95a90a3e95
spl set id: f18a3bca-f047-4916-e053-2995a90a7337

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.