THERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT WITH COLLOIDAL OATMEAL- oatmeal cream

THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal by

Drug Labeling and Warnings

THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal Oatmeal by is a Otc medication manufactured, distributed, or labeled by THERAPLEX, LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Colloidal Oatmeal 1%

Purpose

Skin Protectant

Uses

temporarily protects and helps relive minor skin irritation and itching due to: eczema rashes

Warnings

For external use only

When using this product

do not get into eyes.

Stop use and ask a doctor if

• condition worsens
• symptoms last 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, or as directed by your doctor.

Other information

• store at room temperature
• keep from freezing

Inactive Ingredients

cyclomethicone, ozokerite wax, petrolatum (special fraction)

Questions?

email help@theraplex.com

Package Labeling:

INGREDIENTS AND APPEARANCE

THERAPLEX ECZEMA THERAPY MOISTURIZING SKIN PROTECTANT WITH COLLOIDAL OATMEAL 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82280-618
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE (UNII: NMQ347994Z)
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82280-618-00	85.05 g in 1 JAR; Type 0: Not a Combination Product	06/04/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/04/2025

Labeler - THERAPLEX, LLC (118005210)

Registrant - Pure Source, LLC (080354456)