CORRECT COMBO- glycerin cream 
MIZON CO., LTD.

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.

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ACTIVE INGREDIENT

Active ingredient: Glycerin 20%

INACTIVE INGREDIENT

Inactive ingredients:
Betula Platyphylla Japonica Juice, Ethyl Hexylmethoxycinnamate, Neopentyl Glycol Diheptanoate, Titanium Dioxide, Triethoxy Caprylylsilane, Cyclopentasiloxane, Cyclohexasiloxane, Hexyl Laurate, Peg-10 Dimethicone, Stearic Acid, Alumina, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethicone, Diisostearyl Malate, Cetyl Peg/Ppg-10/1 Dimethicone, Niacinamide, Butylene Glycol, Triethylhexanoin, Copernicia Cerifera (Carnauba) Wax, Scutellaria Baicalensis Root Extract, Paeonia Suffruticosa Root Extract, Sodium Chloride, Sodium Hyaluronate, Ozokerite, Polymethyl Methacrylate, Phenyl Trimethicone, Sorbitan Isostearate, Adenosine, Tocopheryl Acetate, Beta Glucan, Sodium Pca, Betain, Sorbitol, Glycine, Alanine, Proline, Serine, Threonine, Arginine, Lysine, Glutamic Acid, Biosaccharide Gum-1, Adansonia Digitata Seed Extract, Paeonia Lactiflora Root Extract, Convallaria Majalis Root Extract, Magnolia Liliflora Flower Extract, Lilium Candidum Flower Extract, Leontopodium Alpinum Flower/Leaf Extract, Euterpe Oleracrea Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Vaccinium Macrocaron (Cranberry) Fruit Extract, Rubus Fruticosus (Blackberry) Fruit Extract, Sambucus Nigra Fruit Extract, Copper Tripeptide-1, Placental Protein, Brassica Oleracea Italica (Broccoli) Extract, Medicago Sativa (Alfalfa) Extract, Brassica Oleracea Capitata (Cabbage) Leaf Extract, Triticum Vulgare (Wheat) Germ Extract, Brassica Campestris (Rapeseed) Extract, Raphanus Sativus (Radish) Seed Extract, Ceramide 3, Moringa Oleifera Seed Oil, Arnica Montana Flower Extract, Artemisia Absinthium Extract, Achillea Millefolium Extract, Gentiana Lutea Root Extract, Glycine Soja (Soybean) Sprout Extract, Phaseolus Radiatus Seed Extract, Coix Lacryma-Jobi Ma-Yuen Seed Extract, Sesamum Indicum (Sesame) Seed Extract, Oryza Sativa (Rice) Germ Extract, Hordeum Distichon (Barley) Extract, Polygonum Fagopyrum Seed Extract, Glycyrrhiza Uralensis (Licorice) Root Extract, Plantago Major Leaf Extract, Poria Cocos Extract, Coix Lacryma-Jobi Ma-Yuen Seed Extract, Angelica Gigas Extract, Polygonatum Odoratum Extract (And Astragalus Membranaceus Root Extract, Cornus Officinalis Fruit Extract, Artemisia Capillaris Leaf Extract, Rehmannia Glutinosa Root Extract, Butyrospermum Parkii(Shea Butter), Mangifera Indica (Mango) Seed Butter, Argania Spinosa Kernel Oil, Simmondsia Chinensis(Jojoba) Seed Oil, Hippophae Rhamnoides Oil, Gardenia Yellow Color, Gardenia Red, Theobroma Cacao(Cocoa) Extract, Mannitol, Iron Oxides, Shellac, Hydrogenated Lecithin, Boron Nitride, Acrylates/Ammonium Methacrylate Copolymer, Fragrance

PURPOSE

Purpose: Skin Protectant

WARNINGS

Warnings:
1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.
2. Do not use on scarred skin, or if you have dermatitis or eczema.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of reach of babies and children

INDICATIONS AND USAGE

Indications and Usage:
1. Always replace cap after use
2. Keep away from direct sunlight or heat.

DOSAGE AND ADMINISTRATION

Dosage and Administration:
Apply a liberal amount onto face after applying activator or cleansing.
Tap applied face softly for better absorption.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

Image of carton

CORRECT COMBO 
glycerin cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin7 mg  in 35 mL
Inactive Ingredients
Ingredient NameStrength
NIACINAMIDE (UNII: 25X51I8RD4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57718-020-0135 mL in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2013
Labeler - MIZON CO., LTD. (557815570)
Registrant - MIZON CO., LTD. (557815570)
Establishment
NameAddressID/FEIBusiness Operations
MIZON CO., LTD.557815570manufacture(57718-020)

Revised: 5/2013
Document Id: 3b5dca2e-0d2a-4ad6-a856-ac2f35474114
Set id: cbc57201-e428-4027-ab85-36c82b670678
Version: 1
Effective Time: 20130503
 
MIZON CO., LTD.