Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76%(0.1% W/V fluoride ion)

Purpose

Anticavity toothpaste

Use

helps pretect against cavities

Warnings

Keep out of reach of children

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center rightaway. under 6 years of age.

Directions


Adults and children 2 years of age & older:	Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 6 years of age:	Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.

Children under 2 years of age: Consult a dentist or doctor.

Other information

Store in a cool place, below 86°F, away from heat
Do not use if quality seal is broken or missing

Inactive ingredients

Calcium Carbonate, Water, Sorbitol, Glycerin, Silica, Alcohol, Sodium Lauryl Sulfate, Flavor, Carrageenan, Cellulose Gum, Hydroxyethylcellulose, Sodium Saccharin, Sodium Silicate, Trisodium Phosphate, Thymol, Rosa Canina Fruit Oil

Questions or comments

For customer enquiries, please contact:customer.service@whiteglo.com White Glo USA INC. 25 Suffolk Court, Hauppauge, NY, 11788 USA. www.whiteglo.com

Package Labeling:

Outer Package3 Inner Package3

WHITE GLO MOUTHWASH PROTECTION
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73656-017

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73656-017-00	1 in 1 KIT	11/01/2021

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 TUBE	150 g

Part 1 of 1

WHITE GLO MOUTHWASH PROTECTION
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC:73656-018
Route of Administration	DENTAL

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

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCOHOL (UNII: 3K9958V90M)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
CARRAGEENAN (UNII: 5C69YCD2YJ)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM SILICATE (UNII: IJF18F77L3)
THYMOL (UNII: 3J50XA376E)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)

#	Item Code	Package Description
Packaging
1	NDC:73656-018-00	1 in 1 CARTON
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 Drug	M021	11/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	11/01/2021

Labeler - WHITE GLO USA INC (117345666)

White Glo Toothpaste Mouthwash Protection + Toothbrush