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 & older	Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
Children under 2 years	Instruct in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary.
Children 2 to 6 years	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, Glycerine, Sodium Lauryl Sulphate, Flavor, Charcoal, Cellulose Gum, Chondrus Crispus, Tetrasodium Pyrophosphate, Sodium Saccharin, Sodium Benzoate

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:

Label Box

WHITE GLO CHARCOAL
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:73656-009

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73656-009-00	1 in 1 KIT	03/16/2020

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

Part 1 of 1

WHITE GLO CHARCOAL
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC:73656-010
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
SORBITOL (UNII: 506T60A25R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM BENZOATE (UNII: OJ245FE5EU)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:73656-010-00	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	03/16/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M021	03/16/2020

Labeler - WHITE GLO USA INC (117345666)

WHITE GLO CHARCOAL Kit