WHITE GLO CHARCOAL DEEP STAIN REMOVER TOOTH- sodium monofluorophosphate paste
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 Charcoal Deep Stain Remover Toothpaste

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

68368-156-00

WHITE GLO CHARCOAL DEEP STAIN REMOVER TOOTH
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68368-156
Route of Administration	DENTAL

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)

Revised: 2/2021

Document Id: bbb20b4b-d365-787b-e053-2995a90a084e

Set id: a514d6d3-7c03-4377-b5cb-af5aadfcd291

Version: 2

Effective Time: 20210219

Barros Laboratories Pty Limited