WHITE GLO SMOKERS FORMULA (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [BARROS LABORATORIES PTY LIMITED]

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WHITE GLO SMOKERS FORMULA (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [BARROS LABORATORIES PTY LIMITED]
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NDC 68368-152-00
Set ID ea8efcc9-66c5-4227-a5f1-8d67a0359e15
Category HUMAN OTC DRUG LABEL
Packager Barros Laboratories Pty Limited
Generic Name
Product Class
Product Number
Application Number PART355
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  • DRUG FACTS

  • Active Ingedients

    Sodium monofluorophosphate 0.76%

  • Purpose

    Anticavity toothpaste

  • Use

    helps protect against cavities

  • Warnings

  • Keep out of the reach of children under 6 years of age.

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.
    • do not swallow
    • to minimize swalowing use a pea-sized amount in children under 6
    • supervise children's brushing until good habits are established
    • children under 2 years ask a dentist.
  • Inactive Ingredients

    Calcium Carbonate, Aqua (water), Glycerin, sorbitol, silica, aroma (flavor), Solum Diatomease (Diatomaceous Earth), sodium lauryl sulfate, carboxymethyl hydroxylcellulose, chondrus crispus (carrageenan), ci 77891 (titanium dioxide), sodium saccharin, rosa canina fruit oil.

  • For Customer enquires, please contact:

    questions@whiteglo.net

  • SPL UNCLASSIFIED SECTION

    DEVELOPED AND FORMULATED BY

    BARROS LABORATORIES PTY LTD AUSTRALIA Trademarks "WHITE GLO" Reg'd

    Barros Laboratories P/L. White Glo House,

    10 Narabang Way Belrose, New South Wales 2085 Australia

    Product Manufactured in China under strict quality control and standards.

    Distributed by Brandfarm USA LLC., 3072 Patricia Ave, Los Angeles, CA 90064 USA

  • Package Label

    Extra Strength Whitening Toothpaste

    White Glo

    Smokers Formula

    Quality Formulated for Film Actors & Models

    Effective Whitening Formula

    Low Abrasion - Safe for Daily Use

    Flouride Protection Against Cavities

    NET WT

    5.2 oz

    150g

    Smokersfront

    SmokersBack

  • INGREDIENTS AND APPEARANCE
    WHITE GLO SMOKERS FORMULA 
    sodium monofluorophosphate paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68368-152
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68368-152-001 in 1 BOX12/03/201412/01/2023
    1150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35512/03/201412/01/2023
    Labeler - Barros Laboratories Pty Limited (751813452)
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