WHITE GLO MAXIMUM WHITE CHARCOAL- sodium monofluorophosphate kit

White Glo Maximum White Charcoal by

Drug Labeling and Warnings

White Glo Maximum White Charcoal 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, Water, Silica, Glycerin, Sodium Bicarbonate, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Carrageenan, Sodium Saccharin, Sodium Benzoate, Tetrasodium Pyrophosphate, Bamboo Charcoal, 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:

INGREDIENTS AND APPEARANCE

WHITE GLO MAXIMUM WHITE CHARCOAL 
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73656-013

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-013-00	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 MAXIMUM WHITE CHARCOAL 
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC: 73656-014
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-014-00	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)