HANSKIN BIO ORIGIN THE EYE dimethicone cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)
Available from:
Celltrion Skincure Co.,Ltd.
INN (International Name):
Dimethicone
Composition:
Dimethicone 1.01 g in 30 mL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final

HANSKIN BIO ORIGIN THE EYE- dimethicone cream

Celltrion Skincure 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.

----------

ACTIVE INGREDIENT

Active ingredient: Dimethicone 3.37%

INACTIVE INGREDIENT

Inactive ingredients: Water, Dipropylene Glycol, Butylene Glycol, Hydrogenated Polydecene, Glyceryl

Stearate, Glycerin Cetearyl Alcohol, Cyclopentasiloxane, Niacinamide, Helianthus Annuus (Sunflower)

Seed Oil, PEG-100 Stearate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Stearic

Acid, PEG-150 Distearate, Portulaca Oleracea Extract, Polysorbate 60, Tocopheryl Acetate,

Caprylic/Capric Triglyceride, Bis-PEG-18 Methyl Ether Dimethyl Silane, Methyl Methacrylate

Crosspolymer, Triethylhexanoin, Cetearyl Olivate, Sorbitan Olivate, Caprylyl Glycol,

Phytostearyl/Behenyl/Octyldodecyl Lauroyl Glutamate, Hydroxyethyl Acrylate/Sodium

Acryloyldimethyl Taurate Copolymer, Cetyl-PG Hydroxyethyl Palmitamide, Squalane,

Dimethicone/Vinyl Dimethicone Crosspolymer, Dipotassium Glycyrrhizate, Phenoxyethanol,

Carbomer, Fragrance (Parfum), Tromethamine, Saccharide Isomerate, Hydrogenated Lecithin,

Polyglyceryl-10 Stearate, Adenosine, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables,

Glyceryl Polymethacrylate, Disodium EDTA, Sorbitan Isostearate, Dextrin, Theobroma Cacao (Cocoa)

Extract, Saccharomyces Ferment Filtrate, Pistacia Lentiscus (Mastic) Gum, Citric Acid, Sodium Citrate,

Acetyl Hexapeptide-8

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or

rashes appear. If any adverse reaction occurs, stop using the product and consult with the dermatologist

if symptoms persist. Do not use on deep puncture wounds, animal bites or serious burns. Keep out of

reach of children.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: Provides a wrinkle-smoothing care to eye area while Acetyl Hexapeptide-8

supports the firming of skin.

DOSAGE & ADMINISTRATION

Dosage & Administration: - After ritual cleansing and toning, follow with serum/essence prior to

applying facial cream. - After using serum/essence and before layering under facial cream, gently dab a

small amount of the cream around eyelids and massage under the eye rim area with your fingertips until

well absorbed. - For better results, recommend to use it every morning and night after ritual

moisturization.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HANSKIN BIO ORIGIN THE EYE

dimethicone cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:4746 9 -26 0

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Dimethico ne (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

Dime thic o ne

1.0 1 g in 30 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Dipro pylene Glyco l (UNII: E10 7L8 5C40 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

Celltrion Skincure Co.,Ltd.

1

NDC:4746 9 -26 0 -0 2

1 in 1 CARTON

12/20 /20 16

1

NDC:4746 9 -26 0 -0 1

30 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt347

12/20 /20 16

Labeler -

Celltrion Skincure Co.,Ltd. (690306386)

Registrant -

Celltrion Skincure Co.,Ltd. (690306386)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Celltrio n Skincure Co .,Ltd.

6 9 0 30 6 38 6

re la be l(4746 9 -26 0 )

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Co smax, Inc

6 8 9 0 49 6 9 3

ma nufa c ture (4746 9 -26 0 )

Revised: 1/2017

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