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HANSKIN BIO ORIGIN THE AMPOULE SERUM

Dosage form: cream
Ingredients: Dimethicone 1.50g in 60mL
Labeler: Celltrion Skincure Co.,Ltd.
NDC Code: 47469-170

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 2.50%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Glycerin, Cyclopentasiloxane, Dipropylene Glycol, Helianthus Annuus (Sunflower) Seed Oil, Niacinamide, PEG-10 Glyceryl Stearate, Phytosteryl/Behenyl/Octyldodecyl Lauroyl Glutamate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Lactobacillus/Soybean Ferment Extract, Saccharomyces/Potato Extract Ferment Filtrate, Saccharomyces/Barley Seed Ferment Filtrate, Saccharide Isomerate, Adenosine, Portulaca Oleracea Extract, Acetyl Hexapeptide-8, Pistacia Lentiscus (Mastic) Gum, Triisostearin, Butylene Glycol, Caprylic/Capric Triglyceride, Polyglyceryl-2 Distearate, Behenyl Alcohol, Stearyl Alcohol, PEG-75, Caprylyl Glycol, Methyl Methacrylate Crosspolymer, Cetyl-PG Hydroxyethyl Palmitamide, Titanium Dioxide (CI 77891), Tocopheryl Acetate, Fragrance (Parfum), Phenoxyethanol, Synthetic Fluorphlogopite, Acrylates/C10-30 Alkyl-Acrylate Crosspolymer, Sodium Citrate, Sodium Hyaluronate, Hydrogenated Lecithin, Polyglyceryl-10 Stearate, Tromethamine, Disodium EDTA, 1,2-Hexanediol, Saccharomyces Ferment Filtrate, Ethylhexylglycerin, Tin Oxide (CI 77861), Citric Acid

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Do not use on deep puncture wounds, animal bites or serious burns. Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

Indications & Usage: - Skin 3R System in this Ampoule Serum enhances its skin-treating benefit for delicate complexion and helps make the skin glow like a beautiful aurora. - Helps brighten the skin tone and improve the look of wrinkles.

DOSAGE & ADMINISTRATION

Dosage & Administration: - After using your daily lotion, take 1~2 drops onto palm with the spuit and dispense generously over your face in a massaging motion until the serum is well absorbed into skin.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HANSKIN BIO ORIGIN THE AMPOULE SERUM 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47469-170
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (DIMETHICONE) Dimethicone1.50 g  in 60 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Packaging
#Item CodePackage Description
1NDC:47469-170-021 BOTTLE, PUMP in 1 CARTON
1NDC:47469-170-0160 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/01/2016
Labeler - Celltrion Skincure Co.,Ltd. (690306386)
Registrant - Celltrion Skincure Co.,Ltd. (690306386)
Establishment
NameAddressID/FEIOperations
Celltrion Skincure Co.,Ltd.690306386relabel(47469-170)
Establishment
NameAddressID/FEIOperations
Cosmax, Inc689049693manufacture(47469-170)

Revised: 05/2017
 
Celltrion Skincure Co.,Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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