WHITE GLO 2IN1 TOOTH W MOUTHWASH- sodium monofluorophosphate paste, dentifrice

White Glo 2in1 Tooth w Mouthwash by

Drug Labeling and Warnings

White Glo 2in1 Tooth w Mouthwash by is a Otc medication manufactured, distributed, or labeled by BARROS LABORATORIES PTY LIMITED. 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 86ºF, away from heat
• Do not use if quality seal is broken or missing

Inactive ingredients

Calcium Carbonate, Aqua (Water), Glycerin, Sorbitol, Silica, Alcohol Denat., Aroma (Flavour), Sodium Lauryl Sulphate, Carboxymethyl Hydroxyethylcellulose, Chondrus Crispus (Carrageenan), Sodium Saccharin, Rosa Canina Fruit Oil, CI 77891 (Titanium Dioxide)

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: 68368-001-10

Package Labeling: 68368-001-07

Package Labeling: 68368-001-05

Package Labeling: 68368-001-04

Package Labeling: 68368-001-03

INGREDIENTS AND APPEARANCE

WHITE GLO 2IN1 TOOTH W MOUTHWASH 
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68368-001
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)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ALCOHOL (UNII: 3K9958V90M)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CHONDRUS CRISPUS (UNII: OQS23HUA1X)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68368-001-10	1 in 1 BOX	01/01/2020
1		10 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68368-001-07	1 in 1 BOX	01/01/2020
2		7 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68368-001-05	1 in 1 BOX	01/01/2020
3		5 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 68368-001-04	1 in 1 BOX	01/01/2020
4		4 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 68368-001-03	1 in 1 BOX	01/01/2020
5		3 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 final	part355	01/01/2020

Labeler - BARROS LABORATORIES PTY LIMITED (751813452)