WHITE GLO MICELLAR- sodium monofluorophosphate kit

WHITE GLO MICELLAR by

Drug Labeling and Warnings

WHITE GLO MICELLAR 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 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

Calcium carbonate, water, sorbitol, glycerin, hydrated silica, sodium lauryl sulfate, flavor, sodium saccharin, sodium silicate, trisodium phosphate, cellulose gum, hydroxyethylcellulose, cocamidopropyl betaine, propylene glycol, FD&C Red 40

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 MICELLAR 
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73656-003

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-003-00	1 in 1 KIT	02/15/2020

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

Part 1 of 1

WHITE GLO MICELLAR 
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC: 73656-004
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
CALCIUM CARBONATE (UNII: H0G9379FGK)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
METHYL SALICYLATE (UNII: LAV5U5022Y)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM SILICATE (UNII: IJF18F77L3)
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-004-00	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	02/15/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	02/15/2020

Labeler - WHITE GLO USA INC (117345666)