PRESTIGE JEJU SNAIL- glycerin, niacinamide emulsion

PRESTIGE JEJU SNAIL by

Drug Labeling and Warnings

PRESTIGE JEJU SNAIL by is a Otc medication manufactured, distributed, or labeled by TONYMOLY CO.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Glycerin 8.98%, Niacinamide 2.0%

INACTIVE INGREDIENT

Inactive Ingredients: Snail Secretion Filtrate, Water, Hydrogenated Polydecene, Cetyl Ethylhexanoate, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Cyclopentasiloxane, Macadamia Ternifolia Seed Oil, Cetearyl Alcohol, Hydrogenated Vegetable Oil, Glyceryl Stearate, PEG-100 Stearate, Sorbitan Stearate, Cyclohexasiloxane, Betaine, Palmitic Acid, Carbomer, Polyacrylate-13, Stearic Acid, Tromethamine, Phenoxyethanol, Dimethicone, Tocopheryl Acetate, Chlorphenesin, Polyisobutene, Ethylhexylglycerin, Caprylyl Glycol, Xanthan Gum, Citrus Limon (Lemon) Peel Oil, Lecithin, Adenosine, Polysorbate 20, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Sorbitan Isostearate, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Rosa Canina Fruit Oil, Citrus aurantium dulcis (orange) peel oil, Citrus Aurantifolia (Lime) Oil, Camellia Japonica Flower Extract, Pinus Sylvestris Leaf Oil, Eucalyptus Globulus Leaf Oil, Gold, Citrus Unshiu Fruit Extract, Dipropylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Ficus Carica (Fig) Fruit Extract, Cinnamomum camphora (camphor) leaf extract, Gardenia Jasminoides Fruit Extract, Opuntia Coccinellifera Fruit Extract, Citric Acid, 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

INGREDIENTS AND APPEARANCE

PRESTIGE JEJU SNAIL 
glycerin, niacinamide emulsion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-318
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	Glycerin	11.22 g  in 125 mL
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	2.50 g  in 125 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-318-02	1 in 1 CARTON	07/01/2016
1	NDC: 59078-318-01	125 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2016

Labeler - TONYMOLY CO.,LTD (688216798)

Registrant - TONYMOLY CO.,LTD (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
TONYMOLY CO.,LTD		688216798	manufacture(59078-318)