Omeza Skin Protectant by Omeza, LLC Omeza Skin Protectant

Omeza Skin Protectant by

Drug Labeling and Warnings

Omeza Skin Protectant by is a Otc medication manufactured, distributed, or labeled by Omeza, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

OMEZA SKIN PROTECTANT- oatmeal 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

Drug Facts

Active ingredients

Colloidal oatmeal 2.5%

Purpose

skin protectant

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 within a few days

Keep out of reach of children.

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

Directions

Apply as needed

Inactive ingredients

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

Questions or Comments

1-888-886-6392

Package Labeling:

OMEZA SKIN PROTECTANT 
oatmeal gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73033-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETYL ESTERS WAX (UNII: D072FFP9GU)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
COCONUT OIL (UNII: Q9L0O73W7L)
COD LIVER OIL (UNII: BBL281NWFG)
GLYCERYL LAURATE (UNII: Y98611C087)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
PALM OIL (UNII: 5QUO05548Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73033-005-00	10 in 1 BOX	12/01/2021	11/29/2022
1		1 in 1 POUCH
1		2 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/01/2021	11/29/2022

Labeler - Omeza, LLC (118802035)

Revised: 12/2022

Document Id: ef43d097-54b4-048a-e053-2a95a90a3302

34390-5

Set id: 99da0d44-d659-40bb-a87c-77bc482922e0

Version: 3

Effective Time: 20221207

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