EASYDEW DAILY DOUBLE HYDRA ESSENCE by DN Company Co., Ltd. / Cosmax, Inc.

EASYDEW DAILY DOUBLE HYDRA ESSENCE by

Drug Labeling and Warnings

EASYDEW DAILY DOUBLE HYDRA ESSENCE by is a Otc medication manufactured, distributed, or labeled by DN Company Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EASYDEW DAILY DOUBLE HYDRA ESSENCE- dimethicone cream 
DN Company Co., 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

Active Ingredient: Dimethicone 1.0%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Ethylhexyl Palmitate, Cocos Nucifera (Coconut) Oil, Glycerin, Isopropyl Palmitate, Butyrospermum Parkii (Shea) Butter, Pentylene Glycol, Glyceryl Stearate, Butylene Glycol, Cetearyl Alcohol, PEG-100 Stearate, Sorbitan Stearate, PEG-40 Stearate, Phenoxyethanol, Stearic Acid, Caprylyl Glycol, Fragrance(Parfum), Carbomer, Tromethamine, Macadamia Ternifolia Seed Oil, Ethylhexylglycerin, Alcohol, Caprylic/ Capric Triglyceride, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Tocopheryl Acetate, Squalane, Disodium EDTA, Ceramide 3, Phytosphingosine, 1,2-Hexanediol, Hydrogenated Lecithin, Polysorbate 60, Sorbitan Isostearate, Sodium Stearoyl Glutamate, Sucrose, Sodium Ascorbyl Phosphate, Arginine, PCA, Serine, sh-Oligopeptide-1, Alanine, Threonine, Mourera Fluviatilis Extract,

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Keep out of reach of children. Do not use in wounds, eczemas or dermatitis. If you develop rash, itchiness or irritation, discontinue the use. Keep in a cool and dry placer.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: This hydra essence containing serine, one of the key components of N.M.F. (Natural Moisturizing Factors) helps retain moisture forming a dense film over the surface of the skin .

DOSAGE & ADMINISTRATION

Dosage & Administration: After using the toner, apply a proper amount and lightly tap until it is absorbed into the skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EASYDEW DAILY DOUBLE HYDRA ESSENCE 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-090
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.4 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl Palmitate (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-090-02	1 in 1 CARTON	07/15/2016	11/01/2019
1	NDC: 60565-090-01	40 mL in 1 TUBE; 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	07/15/2016	11/01/2019

Labeler - DN Company Co., Ltd. (688369859)

Registrant - DN Company Co., Ltd. (688369859)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60565-090)

Revised: 12/2019

Document Id: 7d51e98b-a38a-473a-93d9-a531307cbb2e

34390-5

Set id: 9937f2d0-14a9-4890-9aa6-8baffbbb8d45

Version: 3

Effective Time: 20191231

 

DN Company Co., Ltd.