WHITE GLO PROFESSIONAL CHOICE TWIN PACK- sodium fluoride kit

White Glo Professional Choice Twin Pack by

Drug Labeling and Warnings

White Glo Professional Choice Twin Pack 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/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 860 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, rosa canina (rose hip) fruit oil

Questions or comments

For customer enquiries, please contact: customer.service@whiteglo.com White Glo USA INC. 42 West Campbell Avenue, Third Floor Campbell, California 9500. www.whiteglo.com

Package Labeling:

INGREDIENTS AND APPEARANCE

WHITE GLO PROFESSIONAL CHOICE TWIN PACK 
sodium fluoride kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73656-024

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-024-00	1 in 1 BOX	10/19/2023
1		1 in 1 KIT

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 TUBE	300 g

Part 1 of 1

WHITE GLO PROFESSIONAL CHOICE 
sodium fluoride paste, dentifrice

Product Information
Item Code (Source)	NDC: 73656-025
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM SILICATE (UNII: IJF18F77L3)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
CALCIUM CARBONATE (UNII: H0G9379FGK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-025-00	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	10/19/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	10/19/2023

Labeler - WHITE GLO USA INC (117345666)

Establishment
Name	Address	ID/FEI	Business Operations
Suzhou Baozi Healthy Technology Co.,Ltd		529638300	manufacture(73656-025)