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

EASYDEW DAILY DOUBLE HYDRA by

Drug Labeling and Warnings

EASYDEW DAILY DOUBLE HYDRA 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- 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 1.5%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Butylene Glycol, Cetyl Ethylhexanoate, Ethylhexyl Palmitate, Hydrogenated Polydecene, Glyceryl Stearate, Dipropylene Glycol, Cyclopentasiloxane, Cetearyl Alcohol, Hydrogenated Vegetable Oil, Polysorbate 60, 1,2-Hexanediol, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Panthenol, Trehalose, Chondrus Crispus Extract, Saccharum Officinarum (Sugarcane) Extract, PEG-100 Stearate, Cetearyl Olivate, Sorbitan Olivate, Sorbitan Sesquioleate, Phenoxyethanol, Caprylyl Glycol, Carbomer, Tromethamine, Fragrance(Parfum), Alcohol, Caprylic/Capric Triglyceride, Disodium EDTA, Tocopheryl Acetate, Hydrogenated Lecithin, 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 place.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: This hydra cream containing serine, one of the key components of N.M.F. (Natural Moisturizing Factors), improves skin hydration and helps strengthen skin barrier.

DOSAGE & ADMINISTRATION

Dosage & Administration: In the last step of skin care, apply a proper amount to the areas where you desire.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EASYDEW DAILY DOUBLE HYDRA 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60565-080
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	Dimethicone	0.9 g  in 60 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60565-080-02	1 in 1 CARTON	07/15/2016	11/01/2019
1	NDC: 60565-080-01	60 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(60565-080)

Revised: 12/2019

Document Id: bdd9582f-5cb1-4a57-ade8-9c70c36ba9ae

34390-5

Set id: 8bfe63a0-0356-406a-81bc-5f5f24c0e820

Version: 3

Effective Time: 20191230

 

DN Company Co., Ltd.