GLADSKIN ECZEMACT ECZEMA- colloidal oatmeal cream

GLADSKIN ECZEMACT ECZEMA by

Drug Labeling and Warnings

GLADSKIN ECZEMACT ECZEMA by is a Otc medication manufactured, distributed, or labeled by Micreos North America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Colloidal Oatmeal (0.02%)

Purpose

Skin Protectant

Uses

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

Warnings

For external use only.

When using this product do not get into eyes.

Stop use and ask a doctor if:

• Conditions worsen
• 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

Inactive Ingredients

Water, Glycerin, Petrolatum, Mineral Oil, Cetearyl Alcohol, Ceteareth-20, Arginine HCl, Sodium Chloride, Tromethamine, Calcium Chloride, sr-(Methionyl Staphylococcus Simulans Polypeptide-1 Dipeptide-53 Staphylococcus Phage 2638A Polypeptide-1)*

*Micreobalance™is a proprietary smart protein that rebalances the skin microbiome.

Questions?

(888) 802-1668

Company Information

Distributed by Micreos North America, Inc. Encinitas, CA 92024

gladskin.com

Product Packaging

INGREDIENTS AND APPEARANCE

GLADSKIN ECZEMACT ECZEMA 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73105-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	0.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MINERAL OIL (UNII: T5L8T28FGP)
ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
TROMETHAMINE (UNII: 023C2WHX2V)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73105-003-50	1 in 1 CARTON	10/05/2023
1		50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 73105-003-00	1 in 1 CARTON	10/05/2023
2		100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/05/2023

Labeler - Micreos North America, Inc. (117342389)