White Glo 2in1 Tooth w Mouthwash

Manufacturer
BARROS LABORATORIES PTY LIMITED
Effective date
2023-07-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:28:53

Label at a glance#

ProductWhite Glo 2in1 Tooth w Mouthwash
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure12 sections

Dosage and administration

 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.1% w/v fluoride ion).

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of reach of children under 6 years of age.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

 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

SPL UNCLASSIFIED SECTION

  • Store in a cool place, below 86ºF, away from heat
  • Do not use if quality seal is broken or missing

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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 LABEL.PRINCIPAL DISPLAY PANEL

10g10gDrug Facts PanelDrug Facts Panel

Package Labeling: 68368-001-07

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling: 68368-001-05

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling: 68368-001-04

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

Package Labeling: 68368-001-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68368-00168368-001-10, 68368-001-07, 68368-001-05, 68368-001-04, 68368-001-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
004bbcd7-9ab9-5809-e063-6294a90a2526c5de52fd-9ad7-4397-8a08-eb0b6dce21842023-07-12WarningsExact identifier
spl id: 004bbcd7-9ab9-5809-e063-6294a90a2526
spl set id: c5de52fd-9ad7-4397-8a08-eb0b6dce2184

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.