WHITE GLO COFFEE TEA DRINKERS FORMULA- 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 Coffee Tea Drinkers Formula 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, 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

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

Coffee & Tea Drinkers 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

CoffeeTeaFront

CoffeeTeaBack

WHITE GLO COFFEE TEA DRINKERS FORMULA
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68368-153
Route of Administration	DENTAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68368-153-00	1 in 1 BOX	12/03/2014	12/01/2023
1		150 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	12/03/2014	12/01/2023

Labeler - Barros Laboratories Pty Limited (751813452)

Revised: 2/2021

Document Id: bbb21f51-3c4c-eaec-e053-2a95a90a0d1e

Set id: e9ba5ce5-23fb-4fc7-82cc-2ee9c3da8c82

Version: 4

Effective Time: 20210219

Barros Laboratories Pty Limited