Label: BETULA ALBA JUICE WHITE GEL FOR MEN- 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 September 23, 2011

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  • ACTIVE INGREDIENT

    Active ingredient: DIMETHICONE 5.44%

  • INACTIVE INGREDIENT

    Inactive Ingredients:
    WATER, BETULA ALBA JUICE, PROPYLENE GLYCOL, TRISILOXANE, BETA-GLUCAN, GLYCERIN, NIACINAMIDE, BETAINE, BUTYLENE GLYCOL, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ALGAE EXTRACT  , DIISOSTEARYL MALATE, MACADAMIA TERNIFOLIA SEED OIL, CYCLOPENTASILOXANE, CETYL ETHYLHEXANOATE, TRIMETHYLSILOXYSILICATE, POLYGLYCERYL-3 METHYLGLUCOSE DISTEARATE, C14-22 ALCOHOLS, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, PEG-40 STEARATE, C12-20 ALKYL GLUCOSIDE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, C12-14 PARETH-12, CAPRYLIC/CAPRIC TRIGLYCERIDE, DIACETYL BOLDINE, HONEY EXTRACT, HYDROLYZED VIOLA TRICOLOR EXTRACT, SODIUM HYALURONATE, XANTHAN GUM, DISODIUM EDTA, METHYLPARABEN, PROPYLPARABEN, PHENOXYETHANOL, FRAGRANCE

  • PURPOSE

    Purpose: This combination of cosmetics / OTC Drug is used for your basic skin care and gives a benefit for  Brightening care.

  • WARNINGS

    Warnings:
    For external use only.
    Avoid contact with eyes.
    Discontinue use if signs of irritation appear.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:
    Keep out of reach of children.

  • INDICATIONS & USAGE

    Indication and usage:
    Following emulsion, pour some on the palm of your hand and apply to skin gently.
    Press down lightly until absorbed.

  • DOSAGE & ADMINISTRATION

    Dosage and administration:
    Take appropriate amount according to your skin condition and apply every morning and night.

  • PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    BETULA ALBA JUICE WHITE GEL  FOR MEN
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76214-026
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.72 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BETULA PUBESCENS RESIN (UNII: 9G931M6I4G)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    BETAINE (UNII: 3SCV180C9W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    C14-22 ALCOHOLS (UNII: B1K89384RJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HONEY (UNII: Y9H1V576FH)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76214-026-0150 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2011
    Labeler - SKINFOOD CO., LTD. (690324173)
    Registrant - SKINFOOD CO., LTD. (690324173)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKINFOOD CO., LTD.690324173manufacture
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