WHITE GLO ADVANTAGE ANTICAVITY FLUORIDE PURPLE- sodium monofluorophosphate paste

White Glo Advantage Anticavity Fluoride Purple by

Drug Labeling and Warnings

White Glo Advantage Anticavity Fluoride Purple 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 86° F, away from heat
• Do not use if quality seal is broken or missing

Inactive ingredients

Calcium Carbonate, Aqua, Glycerin, Sorbitol, Hydrated Silica, Sodium Lauryl Sulfate, Aroma, Sodium Monofluorophosphate, Cellulose Gum, Mentholum, Hydroxyethylcellulose, Sodium Silicate, Sodium Saccharin, Trisodium Phosphate, D&C Red No.33, FD&C Blue No.1

Questions or comments

For customer enquiries, please contact: customer.service@whiteglo.com White Glo USA INC. 42 West Campbell Avenue, Third Floor, Campbell, California, 95008. www.whiteglo.com

Package Labeling:

INGREDIENTS AND APPEARANCE

WHITE GLO ADVANTAGE ANTICAVITY FLUORIDE PURPLE 
sodium monofluorophosphate paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73656-026
Route of Administration	TOPICAL

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)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
SODIUM SILICATE (UNII: IJF18F77L3)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73656-026-00	1 in 1 BOX	04/20/2024
1		100 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	04/20/2024

Labeler - WHITE GLO USA INC (117345666)

Establishment
Name	Address	ID/FEI	Business Operations
Suzhou Baozi Healthy Technology Co.,Ltd		529638300	manufacture(73656-026)