WHITE GLO BIO-ENZYME- sodium monofluorophosphate kit

WHITE GLO BIO-ENZYME by

Drug Labeling and Warnings

WHITE GLO BIO-ENZYME 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

sorbitol, water, hydrated silica, PEG-8, sodium lauryl sulfate, xylitol, flavor, cellulose gum, sodium benzoate, sodium ascorbyl phosphate, tocopherol acetate, bromelain, papain, menthol

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

Pcakage Labeling:

INGREDIENTS AND APPEARANCE

WHITE GLO BIO-ENZYME 
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73656-005

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-005-00	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 BIO-ENZYME 
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC: 73656-006
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)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
XYLITOL (UNII: VCQ006KQ1E)
METHYL SALICYLATE (UNII: LAV5U5022Y)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BROMELAINS (UNII: U182GP2CF3)
PAPAIN (UNII: A236A06Y32)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-006-00	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)