DERMA BREEZE SKIN PROTECTANT CREAM- colloidal oatmeal cream

Derma Breeze Skin Protectant Cream by

Drug Labeling and Warnings

Derma Breeze Skin Protectant Cream by is a Otc medication manufactured, distributed, or labeled by Greyson International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Colloidal oatmeal 1%

Purpose

Skin protectant

Uses

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

• rashes
• eczema

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

• apply as needed

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

INGREDIENTS AND APPEARANCE

DERMA BREEZE SKIN PROTECTANT CREAM 
colloidal oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69475-5411
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69475-5411-0	28.35 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69475-5411-1	1000 g in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/15/2015

Labeler - Greyson International, Inc. (848379215)