Label: CORRECT COMBO- glycerin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated May 3, 2013

If you are a consumer or patient please visit this version.

  • 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

  • INGREDIENTS AND APPEARANCE
    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)