WHITE GLO 2 IN 1 WITH MOUTHWASH- sodium monofluorophosphate paste, dentifrice 
Barros Laboratories Pty Limited

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.

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White Glo 2 in 1 with Mouthwash Extra Strength Whitening Toothpaste

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, denature alcohol (2.5%), aroma (flavor), 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

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

2 in 1 with Mouthwash

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

2in1Front

2in1Back

WHITE GLO 2 IN 1 WITH MOUTHWASH 
sodium monofluorophosphate paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68368-154
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:68368-154-001 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)

Revised: 2/2021
 
Barros Laboratories Pty Limited