PRESTIGE JEJU SNAIL ESSENCE- glycerin, niacinamide cream

PRESTIGE JEJU SNAIL ESSENCE by

Drug Labeling and Warnings

PRESTIGE JEJU SNAIL ESSENCE 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 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

INGREDIENTS AND APPEARANCE

PRESTIGE JEJU SNAIL ESSENCE 
glycerin, niacinamide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-319
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	Glycerin	2.76 g  in 50 mL
Niacinamide (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	Niacinamide	1.0 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Propanediol (UNII: 5965N8W85T)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-319-02	1 in 1 CARTON	07/01/2016
1	NDC: 59078-319-01	50 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(59078-319)