DERMA E ECZEMA RELIEF- oatmeal lotion

Derma E Eczema Relief by

Drug Labeling and Warnings

Derma E Eczema Relief by is a Otc medication manufactured, distributed, or labeled by derma e, Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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

INGREDIENTS AND APPEARANCE

DERMA E ECZEMA RELIEF 
oatmeal lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54108-8712
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 mL

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

Labeler - derma e (148940450)

Registrant - Topiderm, Inc. (049121643)

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