White Glo 2In1 With Mouthwash (Sodium Monofluorophosphate) Paste [Barros Laboratories Pty Limited] -

WHITE GLO 2IN1 WITH MOUTHWASH (SODIUM MONOFLUOROPHOSPHATE) PASTE [BARROS LABORATORIES PTY LIMITED]
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NDC	68368-155-03, 68368-155-05
Set ID	e9ee944b-9fe4-45dd-8134-08157ccfd1a7
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 Ingredient

Sodium Monofluorophosphate 0.76%

Purpose

Anticavity toothpaste
Use

helps protect against cavities
Warnings

Keep out of 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 & older: brush teeth thoroughly after meals or at least twice a day or use 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.
Questions or comments?

questions@white-glo.net
Package Labeling:

INGREDIENTS AND APPEARANCE

WHITE GLO 2IN1 WITH MOUTHWASH
sodium monofluorophosphate paste

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARRAGEENAN (UNII: 5C69YCD2YJ)
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:68368-155-03	3 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018	12/01/2023
2	NDC:68368-155-05	5 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018	12/01/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	01/01/2018	12/01/2023

Labeler - Barros Laboratories Pty Limited (751813452)

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Medic