GLADSKIN ECZEMA- colloidal oatmeal cream

GLADSKIN ECZEMA by

Drug Labeling and Warnings

GLADSKIN 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 twice daily, or more as desired, on skin free of other products.
• Let the cream absorb into skin for 5 minutes before applying other products.

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 natural skin microbiome as it moisturizes.

Other Information

Store at 33°F-75°F.

Questions?

support@gladskin.com

Company Information

Distributed by Micreos North America, Inc. New York, NY 10003

us.gladskin.com

Product Packaging

glad

skin

with micreobalance™

ECZEMA

Cream

Hypoallergenic

Dermatologist Tested

Skin Protectant

50 ml 1.7 fl. oz.

INGREDIENTS AND APPEARANCE

GLADSKIN ECZEMA 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73105-001
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
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
TROMETHAMINE (UNII: 023C2WHX2V)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73105-001-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	12/20/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/20/2019

Labeler - Micreos North America, Inc. (117342389)