DERMACED Deep Therapy Eczema Cream

Active Ingredients:

Colloidal Oatmeal 1.00%

Purpose:

Skin Protectant

USES:

Temporarily protects and helps relieve minor skin irritations due to Eczema and rashes.

WARNINGS:

*For external use only.

*When using this product keep out of eyes.

*Stop use and consult physician if condition worsens; if symptoms last for more than seven days; or if symptoms clear up and occur again within a few days.

*Keep out of reach of Children

DIRECTIONS:

*Apply as needed.

OTHER INGREDIENTS:

Tllantoin, Aqua (Deionized Water), Beeswax, Benzyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Echinacea Angustifolia (Coneflower) Extract, Glyceryl Stearate, Glycyrrhiza Clabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Lanolin, Paraffin Wax, PEG-100 Stearate, Prunus Arnygdalus Dulcis (Sweet Almond) Oil, Simmonclsia Chinensis (jojoba) Oil, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Package Labeling:

Label

DERMACED DEEP THERAPY ECZEMA
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71515-403
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
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LANOLIN (UNII: 7EV65EAW6H)
PARAFFIN (UNII: I9O0E3H2ZE)
PEG-100 STEARATE (UNII: YD01N1999R)
ALMOND OIL (UNII: 66YXD4DKO9)
JOJOBA OIL (UNII: 724GKU717M)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71515-403-04	1 in 1 BOX	07/13/2017	10/06/2020
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	07/13/2017	10/06/2020

Labeler - Dermaced LLC (080703517)

Revised: 10/2023

Document Id: 07223f5c-7262-9174-e063-6394a90a632f

Set id: d754728e-973f-46a1-aef3-e926ab5f1088

Version: 2

Effective Time: 20231007

Dermaced LLC