DERMACED DEEP THERAPY ECZEMA- oatmeal cream

DERMACED Deep Therapy Eczema by

Drug Labeling and Warnings

DERMACED Deep Therapy Eczema by is a Otc medication manufactured, distributed, or labeled by Dermaced LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

DERMACED DEEP THERAPY ECZEMA 
oatmeal cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71515-403
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
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71515-403-04	1 in 1 BOX	07/13/2017
1		118 mL in 1 BOTTLE; 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	07/13/2017

Labeler - Dermaced LLC (080703517)