Label: SCAR SERUM- glycerin cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated February 24, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: Glycerin 5.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Lavandula Angustifolia (Lavender) Water, Ethylhexyl Palmitate, Allium Cepa (Onion) Bulb Extract, Helianthus Annuus (Sunflower) Seed Oil, Dimethyl Sulfone, Cetearyl Alcohol, 1,2-Hexanediol, Stearic Acid/Behenyl Alcohol/Ceteareth-10/Cetearyl Alcohol, Bacillus/Houttuynia Cordata Extract Ferment Filtrate, Sophora Angustifolia Root Extract, Chrysanthellum Indicum Extract, actobacillus/Camellia Sinensis Leaf Ferment Filtrate, Lactobacillus/Honeysuckle Flower Extract Ferment Filtrate, Lactobacillus/Punica Granatum Fruit Ferment Extract, Aspergillus/Camellia Sinensis Leaf Extract Ferment Filtrate, Ecklonia Cava Extract, Camellia Sinensis Leaf Extract, Sodium Hyaluronate, Microcrystalline Wax, Dimethicone, Piper Methysticum Leaf/Root/Stem Extract, Caffeoyl Tripeptide-1, Arginine, Tocopheryl Acetate, Carbomer, Xanthan Gum, Menthol, Rosmarinus Officinalis (Rosemary) Leaf Oil

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings:

    1. Stop usage immediately if any of the below symptoms occur. Continued use could aggravate symptoms, so it is advisable to consult with a dermatologist immediately. 1) Symptoms include but not limited to: red spots, swelling, itchiness. 2) When having the same symptoms as above due to direct sunlight. 2. Do not apply to areas affected by dermatitis, eczema or wounds. 3. Storage and handling: 1) Tightly close lid after each use. 2 Keep out of reach of children 3) Store in a cool dry area, away from sunlight

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Usage

    Usage: Take an appropriate amount and gently apply it on the face

  • Usage

    Usage: Take an appropriate amount and gently apply it on the face

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SCAR SERUM 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70380-310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) Glycerin2.5 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70380-310-0150 mL in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/02/2016
    Labeler - MIGUHARA (689204213)
    Registrant - MIGUHARA (689204213)
    Establishment
    NameAddressID/FEIBusiness Operations
    MIGUHARA689204213manufacture(70380-310)