Daily Moisturizing Lotion

ETHEREAL SKIN CALMING MOISTURIZING CREAM- dimethicone cream
Donegal Bay Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active Ingredient:

Dimethicone 2.0%

Purpose:

Skin Protectant

Uses:

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

Warnings:

For external use only

When using this product, avoid contacting with eyes

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

Keep out of reach of children.

Direction:

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

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

image description

ETHEREAL SKIN CALMING MOISTURIZING CREAM
dimethicone cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Donegal Bay Ltd (068443618)

Registrant - Donegal Bay Ltd (068443618)

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