Label: ULTRA V RENEWDERM PLUS- dimethicone 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 April 1, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: Dimethicone 7.63%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Glycerin, Cyclopentasiloxane, Butylene Glycol, Centella Asiatica Extract, Cyclohexasiloxane, Arbutin , Alcohol , PEG/PPG-19/19 Dimethicone, Beta-Glucan , Biosaccharide Gum-1 , Piper Methysticum Leaf/Root/Stem Extract, Dimethicone/Vinyl Dimethicone Crosspolymer , Glycyrrhiza Glabra (Licorice) Root Extract, Dipotassium Glycyrrhizate, Phellinus Linteus Extract , Phenoxyethanol, Methylparaben, Betaine , Acetyl Hexapeptide-8, Copper Tripeptide-1 , Palmitoyl Oligopeptide, Palmitoyl Tetrapeptide-7, rh-Oligopeptide-1, Sodium Metabisulfite, Glyceryl Acrylate/Acrylic Acid Copolymer, Disodium EDTA, Benzophenone-9, Fragrance, Propylene Glycol, Sodium Hyaluronate

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep out of reach of children.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses: Helps protect skin

  • Directions

    Directions: After facial wash, apply an adequate amount on face and neck. Apply twice a day on normal skin, morning and night, at the last stage of skin care. Tap gently for max absorption.

  • QUESTIONS

    Questions:

    TEL,+82-539-3450

    www.ultravcosmetic.com

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ULTRA V RENEWDERM PLUS 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71975-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) Dimethicone3.81 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71975-010-021 in 1 CARTON01/02/2018
    1NDC:71975-010-0150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34701/02/2018
    Labeler - Ultra V Co., Ltd (689004748)
    Registrant - Ultra V Co., Ltd (689004748)
    Establishment
    NameAddressID/FEIBusiness Operations
    NEW & NEW CO.,LTD.557821160manufacture(71975-010)
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