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PRESTIGE JEJU SNAIL by TONYMOLY CO.,LTD

Medically reviewed on July 29, 2016

Dosage form: cream
Ingredients: Niacinamide 0.90g in 45mL, Dimethicone 0.22g in 45mL
Labeler: TONYMOLY CO.,LTD
NDC Code: 59078-316

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.

ACTIVE INGREDIENT

Active Ingredient: Niacinamide 2.0%, Dimethicone 0.5%

INACTIVE INGREDIENT

Inactive Ingredients: Snail Secretion Filtrate, Macadamia Ternifolia Seed Oil, Hydrogenated Polydecene, Water, Cetearyl Alcohol, Cetyl Ethylhexanoate, Glycol Stearate SE, Panthenol, Caprylic/Capric Triglyceride, Octyldodecyl Myristate, Butyrospermum Parkii (Shea) Butter, Hydrogenated Vegetable Oil, Glyceryl Stearate, Beeswax, Sodium Polyacrylate, PEG-100 Stearate, Cyclopentasiloxane, Ethylhexyl Stearate, Glycerin, Palmitic Acid, Stearic Acid, Hydrogenated Lecithin, Phenoxyethanol, Chlorphenesin, Propanediol, Ethylhexylglycerin, Tocopheryl Acetate, Caprylyl Glycol, Dimethiconol, Laureth-23, Citrus Limon (Lemon) Peel Oil, Lecithin, Adenosine, Trideceth-6, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Disodium EDTA, Alcohol, Citrus aurantium dulcis (orange) peel oil, Beta-Glucan, Citrus Aurantifolia (Lime) Oil, Pinus Sylvestris Leaf Oil, Sodium Hyaluronate, Eucalyptus Globulus Leaf Oil, Gold, Butylene Glycol, Camellia Japonica Flower Extract, Citric Acid, Citrus Unshiu Fruit Extract, Dipropylene Glycol, Pentylene Glycol, 1,2-Hexanediol, Camellia Sinensis Leaf Extract, Centella Asiatica Extract, Ficus Carica (Fig) Fruit 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

PRESTIGE JEJU SNAIL 
niacinamide, dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-316
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Niacinamide (NIACINAMIDE) Niacinamide0.90 g  in 45 mL
Dimethicone (DIMETHICONE) Dimethicone0.22 g  in 45 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Panthenol 
Packaging
#Item CodePackage Description
1NDC:59078-316-021 BOTTLE, PLASTIC in 1 CARTON
1NDC:59078-316-0145 mL in 1 BOTTLE, PLASTIC
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/FEIOperations
TONYMOLY CO.,LTD688216798manufacture(59078-316)

 
TONYMOLY CO.,LTD

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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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