WHITE GLO 2IN1 WITH MOUTHWASH- sodium monofluorophosphate paste

White Glo 2in1 with Mouthwash by

Drug Labeling and Warnings

White Glo 2in1 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 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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68368-155
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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68368-155-03	3 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018
2	NDC: 68368-155-05	5 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2018

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

Labeler - Barros Laboratories Pty Limited (751813452)