GLADSKIN ECZEMA- colloidal oatmeal cream 
Micreos North America, Inc.

----------

GLADSKIN ECZEMA CREAM

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, Trometamol, 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.

Questions?

hello@gladskin.com

Company Information

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

gladskin.com

Product Packaging

1

GLADSKIN ECZEMA 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73105-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73105-002-151 in 1 CARTON12/20/2019
115 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2NDC:73105-002-501 in 1 CARTON12/20/2019
250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
3NDC:73105-002-001 in 1 CARTON12/20/2019
3100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01612/20/201901/04/2024
Labeler - Micreos North America, Inc. (117342389)

Revised: 10/2023
Document Id: 06f9af75-c602-d37b-e063-6394a90a4f6c
Set id: 99ca0f6a-5505-9f62-e053-2a95a90aa97c
Version: 3
Effective Time: 20231005
 
Micreos North America, Inc.