Label: DR VITA PREMIUM VITAMIN C- 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 March 28, 2016

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  • ACTIVE INGREDIENT

    Active Ingredient: DIMETHICONE 3.0%

  • INACTIVE INGREDIENT

    Inactive Ingredients: GLYCERIN, PROPYLENE GLYCOL, CYCLOMETHICONE, ASCORBIC ACID, CYCLOPENTASILOXANE, PEG/PPG-18/18 DIMETHICONE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, CENTELLA ASIATICA EXTRACT, FICUS CARICA (FIG) FRUIT EXTRACT, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HYDROGENATED LECITHIN, 1,2-HEXANEDIOL, PEG/PPG-19/19 DIMETHICONE, ETHYLHEXYLGLYCERIN, ADENOSINE, HYDROGENATED PHOSPHATIDYLCHOLINE, RETINOL, CERAMIDE NP, CHOLESTEROL, CETYL ALCOHOL, STEARYL ALCOHOL, FRAGRANCE, PHENOXYETHANOL

  • PURPOSE

    Purpose: Brightening & wrinkle care

  • WARNINGS

    Warnings: Avoid application to wounded or infected area. Do NOT use if irritation develops. If so, consult a physician immediately. Keep out of reach of children. Cover lid after each use. Store at a cool, dry place, away from direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • INDICATIONS & USAGE

    Indications & Usage: 1. After vitamin mask pack, put size of a nickel on the palm and apply to troubled areas, entire face, or neck evenly. 2. For the face, apply outwards and top-down for the neck.

  • DOSAGE & ADMINISTRATION

    Dosage & Administration: Everyday night

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    DR VITA PREMIUM VITAMIN C 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70545-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.9 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70545-020-0130 g in 1 CARTON; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/01/2016
    Labeler - DAYCELL COSMETICS CO., LTD. (688289734)
    Registrant - DAYCELL COSMETICS CO., LTD. (688289734)
    Establishment
    NameAddressID/FEIBusiness Operations
    DAYCELL COSMETICS CO., LTD.688289734manufacture(70545-020)
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