PRESTIGE JEJU SNAIL ESSENCE- glycerin, niacinamide cream 
TONYMOLY CO.,LTD

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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ACTIVE INGREDIENT

Active Ingredient: Glycerin 5.52%, Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Snail Secretion Filtrate, Propanediol, Alcohol Denat., Water, Cyclopentasiloxane, Tromethamine, Bis-PEG-18 Methyl Ether Dimethyl Silane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Cetyl Ethylhexanoate, Hydrogenated Vegetable Oil, Stearic Acid, Phenoxyethanol, Chlorphenesin, Vegetable Oil, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Caprylyl Glycol, Dimethicone, Alcohol, Phenyl Trimethicone, Citrus Limon (Lemon) Peel Oil, Adenosine, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Sodium Hyaluronate, Citrus aurantium dulcis (orange) peel oil, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Gold, Butylene Glycol, Camellia Japonica Flower Extract, Citrus Unshiu Fruit Extract, Dipropylene Glycol, 1,2-Hexanediol, Pentylene Glycol, Camellia Sinensis Leaf Extract, Ficus Carica (Fig) Fruit Extract, Centella Asiatica Extract, Gardenia Jasminoides Fruit Extract, Cinnamomum camphora (camphor) leaf extract, Opuntia Coccinellifera Fruit Extract, rh-Polypeptide-22

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings: For external use only When using this product do not get into eyes, Stop use and ask a doctor if rash occurs Do not use on - deep puncture wounds - animal bites - serious burns Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

Use

Use: Helps prevent and relieve chapped or cracked skin

Directions

Directions: - Clean the skin thoroughly before using - Apply in daily skin care routine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

PRESTIGE JEJU SNAIL ESSENCE 
glycerin, niacinamide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-319
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin2.76 g  in 50 mL
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) Niacinamide1.0 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Propanediol (UNII: 5965N8W85T)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-319-021 in 1 CARTON07/01/2016
1NDC:59078-319-0150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/01/2016
Labeler - TONYMOLY CO.,LTD (688216798)
Registrant - TONYMOLY CO.,LTD (688216798)
Establishment
NameAddressID/FEIBusiness Operations
TONYMOLY CO.,LTD688216798manufacture(59078-319)

Revised: 7/2016
Document Id: 31fd18df-7fce-4a1f-a932-998c8d3b2985
Set id: e2fbafa5-2bf3-47de-9068-54fd2fa72327
Version: 1
Effective Time: 20160729
 
TONYMOLY CO.,LTD