WHITE GLO CHARCOAL DEEP STAIN REMOVER TOOTH- sodium monofluorophosphate paste

White Glo Charcoal Deep Stain Remover Tooth by

Drug Labeling and Warnings

White Glo Charcoal Deep Stain Remover Tooth 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 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

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 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)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
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: 68368-156-00	1 in 1 PACKAGE	02/01/2018
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	02/01/2018

Labeler - Barros Laboratories Pty Limited (751813452)