Drug Facts

Active ingredient

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

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 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.

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

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, hydrated silica, sodium lauryl sulfate, flavor, sodium saccharin, sodium silicate, trisodium phosphate, cellulose gum, hydroxyethylcellulose, cocamidopropyl betaine, propylene glycol, FD&C Red 40

Questions or comments

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

Package Labeling:

Outer Package Inner Package

WHITE GLO MICELLAR
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73656-003

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73656-003-00	1 in 1 KIT	02/15/2020

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

Part 1 of 1

WHITE GLO MICELLAR
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC:73656-004
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)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73656-004-00	150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	02/15/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	02/15/2020

Labeler - WHITE GLO USA INC (117345666)