Drug Facts

Active ingredient

Sodium monofluorophosphate0.76% (0.1% W/W fluoride ion).

Purpose

Anticavity toothpaste

Use

helps protect 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 right away. 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.

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

Other information

• Store in a cool place, below 860 F, away from heat • Do not use if quality seal is broken or missing

Inactive ingredients

Calcium Carbonate, Sorbitol, Silica, Aqua (Water), Glycerin, Hydrated Silica Sodium Lauryl Sulfate, Cellulose Gum, Aroma (Flavour), Sodium Benzoate, Hydroxyethylcellulose, Sodium Phytate, Sodium Saccharin, Sodium Bicarbonate (Natural Baking Soda), Phthalimidoperoxycaproic Acid. Hydrogen Peroxide, Bromelain, Sodium Phosphate, Mica.

Questions or comments

For customer enquiries, please contact: customer.service@whiteglo.com White Glo USA INC. 42 West Campbell Avenue, Third Floor Campbell, California 9500. www.whiteglo.com

Package Labeling:

Outer Package Inner Package

WHITE GLO PROFESSIONAL WHITE ANTICAVITY
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73656-019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CALCIUM CARBONATE (UNII: H0G9379FGK)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
PHYTATE SODIUM (UNII: 88496G1ERL)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
PHTHALIMIDOPEROXYCAPROIC ACID (UNII: 5OEJ6FAL6C)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
BROMELAINS (UNII: U182GP2CF3)
SODIUM PHOSPHATE (UNII: SE337SVY37)
MICA (UNII: V8A1AW0880)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:73656-019-00	1 in 1 TUBE	08/20/2023
1		115 g in 1 BOX; 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	08/20/2023

Labeler - WHITE GLO USA INC (117345666)

White Glo Professional White AntiCavity Toothpaste