DERMA BREEZE SKIN PROTECTANT CREAM- colloidal oatmeal cream 
Greyson International, Inc.

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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Derma Breeze 1% colloidal oatmeal with Trilexon

Drug Facts

Active ingredient

Colloidal oatmeal 1%

Purpose

Skin protectant

Uses

temporarily protects and helps relieve minor skin irritation and itching due to:

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 immediately

Directions

Inactive ingredients

Water, Medium-Chain Triglycerides, Distearyldimonium Chloride, Saccharide Isomerate, Cetostearyl alcohol, Isocetyl Stearate, Curdlan, Lactic Acid,Glyceryl Monostearate, PPG-51/SMDI Copolymer, Phenoxyethanol, Cetyl Alcohol, Propylene Glycol Stearate, Sodium Chloride, Alpha-Tocopherol Acetate, PEG-10 Soy Sterol

Questions or comments?

1-828-507-7177

PRINCIPAL DISPLAY PANEL

Derma Breeze

1% colloidal oatmeal

WITH TRILEXON

SKIN PROTECTANT

CREAM

Relieves symptoms of dry skin

Gentle Daily Use Formula

Steroid Free

Fragrance Free

Oil Free Substance

db1

db2

db

DERMA BREEZE SKIN PROTECTANT CREAM 
colloidal oatmeal cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69475-5411
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y) OATMEAL10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
CURDLAN (UNII: 6930DL209R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
LACTIC ACID (UNII: 33X04XA5AT)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PPG-51/SMDI COPOLYMER (UNII: KQ9JG3O3YA)  
WATER (UNII: 059QF0KO0R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PROPYLENE GLYCOL STEARATE (UNII: MZM1I680W0)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PEG-10 SOY STEROL (UNII: FG54K98L0Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69475-5411-028.35 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69475-5411-11000 g in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/15/2015
Labeler - Greyson International, Inc. (848379215)

Revised: 11/2015
Document Id: 24fc11d4-5d8c-2f53-e054-00144ff8d46c
Set id: 24736c38-1b5c-6514-e054-00144ff8d46c
Version: 3
Effective Time: 20151120
 
Greyson International, Inc.