WHITE GLO CHARCOAL- sodium monofluorophosphate kit

WHITE GLO CHARCOAL by

Drug Labeling and Warnings

WHITE GLO 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 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:

INGREDIENTS AND APPEARANCE

WHITE GLO CHARCOAL 
sodium monofluorophosphate kit

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

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

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	7.6 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-010-00	150 g in 1 TUBE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/16/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/16/2020

Labeler - WHITE GLO USA INC (117345666)