FDA.reportPublic FDA data

White Glo Charcoal Deep Stain Remover Tooth

Manufacturer
Barros Laboratories Pty Limited
Effective date
2021-02-19
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:51:32

Label at a glance#

ProductWhite Glo Charcoal Deep Stain Remover Tooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure6 sections

Dosage and administration

adult and children 2 years & older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist. do not swallow to minimize swallowing use a pea-sized amount in children under 6 supervise children's brushing until good habits are established children under 2 years: ask a dentist.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monoflourophosphate 0.76%

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  • adult and children 2 years & older: brush teeth thoroughly after meals or at least twice a day or use as directed by dentist.
  • do not swallow
  • to minimize swallowing use a pea-sized amount in children under 6
  • supervise children's brushing until good habits are established
  • children under 2 years: ask a dentist.

Inactive ingredients: 

INACTIVE INGREDIENT SECTION

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

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

68368-156-0068368-156-00

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68368-156-002021-02-19C16284748780-19d75b9d1-186c-f424-e053-dadaa90a57ceWhite Glo Charcoal Deep Stain Remover Toothpaste
68368-156-002020-01-31C16284748780-19d75b9d1-186c-f424-e053-dadaa90a57ceWhite Glo Charcoal Deep Stain Remover Toothpaste

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
68368-15668368-156-00

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM

Source Document#

Source XML

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
bbb20b4b-d365-787b-e053-2995a90a084ea514d6d3-7c03-4377-b5cb-af5aadfcd2912021-02-19WarningsExact identifier
spl id: bbb20b4b-d365-787b-e053-2995a90a084e
spl set id: a514d6d3-7c03-4377-b5cb-af5aadfcd291

Reported adverse events (FAERS/openFDA)#

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