Drug Facts

Active Ingredient

Colloidal Oatmeal 1%

Purpose

Skin protectant

Uses

Temporarily protects and helps relieve minor skin irritation and itching due to Eczema or Rashes

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 to entire body, concentrating on areas of dryness

Inactive ingredients

Allantoin, Arctium Lappa Root Extract, Arctostaphylos Uva-Ursi Leaf Extract, Caprylic/Capric Triglyceride, Cetearyl Glucoside, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower, Coco-Caprylate, Coptis Chinensis Root Extract, Dimethicone, Ethylhexylglycerin, Fagara Zanthoxyloides Fruit Extract, Glycerin, Glyceryl Stearate, Glyceryl Stearate Citrate, Leuconostoc/Radish Root Ferment Filtrate, Melia Azadirachta Leaf, Phenoxyethanol, Potassium Sorbate, Purified Water, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Hydroxide, Stearic Acid, Stearyl Alcohol, Tocopheryl Acetate.

Questions or comments?

Call toll free 1-800-933-9344 or visit dermae.com

Distributed by DERMA E®
Simi Valley, CA, 93065

PRINCIPAL DISPLAY PANEL - 175 mL Tube Label

THERAPEUTIC

CLINICALLY TESTED

Proven
Clean
Beauty™

DERMATOLOGIST
• RECOMMENDED •

DERMA • E

Eczema Relief Lotion

Neem, Burdock &
Bearberry Extracts

for dry skin symptoms
associated with Psoriasis
and Eczema

6 FL OZ / 175 mL

PRINCIPAL DISPLAY PANEL - 175 mL Tube Label

DERMA E ECZEMA RELIEF
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54108-8712
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OATMEAL (UNII: 8PI54V663Y) (OATMEAL - UNII:8PI54V663Y)	OATMEAL	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ALLANTOIN (UNII: 344S277G0Z)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETYL ALCOHOL (UNII: 936JST6JCN)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
COCO-CAPRYLATE (UNII: 4828G836N6)
COPTIS CHINENSIS ROOT (UNII: CXS4LJR7EL)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
WATER (UNII: 059QF0KO0R)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
STEARIC ACID D7 (UNII: T3B081197X)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54108-8712-1	175 mL in 1 TUBE; Type 0: Not a Combination Product	06/14/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH DRUG	M016	06/14/2022

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

Name	Address	ID/FEI	Business Operations
Establishment
Topiderm, Inc.		049121643	MANUFACTURE(54108-8712)

Derma E Eczema Relief