White Glo Charcoal Deep Stain Remover Tooth (Sodium Monofluorophosphate) Paste [Barros Laboratories Pty Limited] -

WHITE GLO CHARCOAL DEEP STAIN REMOVER TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE [BARROS LABORATORIES PTY LIMITED]
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NDC	68368-156-00
Set ID	a514d6d3-7c03-4377-b5cb-af5aadfcd291
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 Monoflourophosphate 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
- adult and children 2 years & older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist.
- do not swallow
- to minimize swallowing 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), Sodium Lauryl Sulphate, Carboxymethyl Hydroxyethylcellulose, Chondrus Crispus (Carrageenan), Charcoal Powder, CI 77891 (Titanium Dioxide), Sodium Saccharin, Rosa Canina Fruit Oil.
Package Labeling

INGREDIENTS AND APPEARANCE

WHITE GLO CHARCOAL DEEP STAIN REMOVER TOOTH
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)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
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:68368-156-00	1 in 1 PACKAGE	02/01/2018	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	02/01/2018	12/01/2023

Labeler - Barros Laboratories Pty Limited (751813452)

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Medic