ETHEREAL SKIN CALMING MOISTURIZING CREAM- dimethicone cream

Ethereal Skin Calming Moisturizing Cream by

Drug Labeling and Warnings

Ethereal Skin Calming Moisturizing Cream by is a Otc medication manufactured, distributed, or labeled by Donegal Bay Ltd, HANGZHOU KARIC COMMODITIES CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Dimethicone 2.0%

PURPOSE

Purpose:

Skin Protectant

INDICATIONS & USAGE

Uses:

Relieves and helps prevent dry, itchy skin. Specially formulated to moisturize, calm, and soothe your skin.

WARNINGS

Warnings:

For external use only

When using this product, avoid contacting with eyes

STOP USE

In case of accidental ingestion get medical help or contact a Poison Control Center immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Direction:

Smooth over irritated, dry skin daily or as needed. For best results apply immediately after shower or/and bath.

INACTIVE INGREDIENT

Inactive Ingredients:

Water, Glycerin, Cetyl Palmitate, Mineral Oil, Colloidal Oatmeal, Caprylic/Capric Triglyceride, Octyldodecanol, Cetyl Alcohol, Glyceryl Stearate, PEG-40 Stearate,  Carbomer, Sodium Hydroxide, Phenoxyethanol, Benzyl Alcohol, Methylparaben, Propylparaben, DMDM Hydantoin

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ETHEREAL SKIN CALMING MOISTURIZING CREAM 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70990-003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL PALMITATE (UNII: 5ZA2S6B08X)
MINERAL OIL (UNII: T5L8T28FGP)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
OCTYLDODECANOL (UNII: 461N1O614Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-40 STEARATE (UNII: ECU18C66Q7)
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZYL ALCOHOL (UNII: LKG8494WBH)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
DMDM HYDANTOIN (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70990-003-01	252 mL in 1 TUBE; Type 0: Not a Combination Product	10/19/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	10/19/2016

Labeler - Donegal Bay Ltd (068443618)

Registrant - Donegal Bay Ltd (068443618)

Establishment
Name	Address	ID/FEI	Business Operations
HANGZHOU KARIC COMMODITIES CO., LTD		526884335	manufacture(70990-003)