WHITE GLO INSTANT WHITE- sodium monofluorophosphate kit

White Glo Instant White by

Drug Labeling and Warnings

White Glo Instant White by is a Otc medication manufactured, distributed, or labeled by WHITE GLO USA INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Sorbitol, Hydrated Silica, Water (Aqua), Sodium Lauryl Sulfate, Polyethylene Glycol 400, Flavor, Xylitol, Sodium Benzoate, Tetrasodium Pyrophosphate, Cellulose Gum, Mica, FD&C Blue No.1

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:

INGREDIENTS AND APPEARANCE

WHITE GLO INSTANT WHITE 
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73656-015

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-015-00	1 in 1 KIT	11/01/2021

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

Part 1 of 1

WHITE GLO INSTANT WHITE 
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC: 73656-016
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.001 mg  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
MICA (UNII: V8A1AW0880)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-016-00	1 in 1 CARTON
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 Drug	M021	11/01/2021

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

Labeler - WHITE GLO USA INC (117345666)