FDA.reportPublic FDA data

Omeza Skin Protectant

Manufacturer
Omeza, LLC
Effective date
2022-09-22
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:53:14

Label at a glance#

ProductOmeza Skin Protectant
Active ingredientOATMEAL
Label structure7 sections

Indications and uses

Temporarily protects and helps relieve minor skin irritation and itching due to • rashes • eczema

Dosage and administration

Apply as needed

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Colloidal oatmeal 2.5%

Purpose

OTC - PURPOSE SECTION

skin protectant

Uses

INDICATIONS & USAGE SECTION

Temporarily protects and helps relieve minor skin irritation and itching due to

• rashes • eczema

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments

OTC - QUESTIONS SECTION

1-888-886-6392

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage LabelDrug FactsDrug Facts

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73033-00573033-005-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CETYL ESTERS WAXD072FFP9GUIACT
ASCORBYL PALMITATEQN83US2B0NIACT
COCONUT OILQ9L0O73W7LIACT
COD LIVER OILBBL281NWFGIACT
GLYCERYL LAURATEY98611C087IACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
PALM OIL5QUO05548ZIACT
OATMEAL8PI54V663YACTIB

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
ef43d097-54b4-048a-e053-2a95a90a330299da0d44-d659-40bb-a87c-77bc482922e02022-12-07WarningsExact identifier
spl set id: 99da0d44-d659-40bb-a87c-77bc482922e0

Reported adverse events (FAERS/openFDA)#

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