WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY- sodium monofluorophosphate kit

White Glo Coffee and Tea Stain Remover Fluoride Anticavity by

Drug Labeling and Warnings

White Glo Coffee and Tea Stain Remover Fluoride Anticavity by is a Otc medication manufactured, distributed, or labeled by WHITE GLO USA INC, Suzhou Baozi Healthy Technology Co.,Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Sodium monofluorophosphate 0.76% (0.1% W/W 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, Aqua (Water), Glycerin, Sorbitol, Silica, Aroma (Flavour), Sodium Lauryl Sulphate, Copernicia Cerifera (Carnauba) Wax, Carboxymethyl Hydroxyethyl-cellulose, Chondrus Crispus (Carrageenan), Sodium Saccharin, Rosa Canina Fruit Oil, CI 77891.

Questions or comments

For customer enquiries, please contact: smiles@whiteglo.com www.whiteglo.com

Package Labeling:

INGREDIENTS AND APPEARANCE

WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY 
sodium monofluorophosphate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73656-030

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-030-00	1 in 1 KIT	09/01/2024

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

Part 1 of 1

WHITE GLO COFFEE AND TEA STAIN REMOVER FLUORIDE ANTICAVITY 
sodium monofluorophosphate paste, dentifrice

Product Information
Item Code (Source)	NDC: 73656-031
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)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARNAUBA WAX (UNII: R12CBM0EIZ)
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: 73656-031-00	1 in 1 BOX
1		150 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 Drug	M021	09/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	09/01/2024

Labeler - WHITE GLO USA INC (117345666)

Establishment
Name	Address	ID/FEI	Business Operations
Suzhou Baozi Healthy Technology Co.,Ltd		529638300	manufacture(73656-031)