WHITE GLO 2 IN 1 WITH MOUTHWASH- sodium monofluorophosphate paste, dentifrice

White Glo 2 in 1 with Mouthwash by

Drug Labeling and Warnings

White Glo 2 in 1 with Mouthwash by is a Otc medication manufactured, distributed, or labeled by Barros Laboratories Pty Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

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

INGREDIENTS AND APPEARANCE

WHITE GLO 2 IN 1 WITH MOUTHWASH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68368-154
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68368-154-00	1 in 1 BOX	12/03/2014
1		150 g in 1 TUBE; Type 0: Not a Combination Product

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

Labeler - Barros Laboratories Pty Limited (751813452)

Establishment
Name	Address	ID/FEI	Business Operations
HUAIAN ZONGHENG BIO-TECH CO., LTD		527152733	manufacture(68368-154)

Establishment
Name	Address	ID/FEI	Business Operations
Yangzhou Hongshengding Chemical Co.,Ltd.		543774755	manufacture(68368-154)