Colgate Anticavity

Manufacturer
Buzz Export Services Pty., Ltd.
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:03

Label at a glance#

ProductColgate Anticavity
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure7 sections

Dosage and administration

 adults and children 2 years of age and older  brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician  children 2 to 6 years    use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)  children under 2 years   ask a dentist or physician 

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Keep out of the 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 and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
 children 2 to 6 years   use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
 children under 2 years  ask a dentist or physician 

Inactive ingredients

INACTIVE INGREDIENT SECTION

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-800-468-6502

Package Labeling:69491-033-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel2Label2BrushBrush

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN2
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY2
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69491-033-01Colgate Anticavity10 g in 1 TUBEPASTE102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69491-033COLGATE ANTICAVITY (SODIUM MONOFLUOROPHOSPHATE) PASTE [BUZZ EXPORT SERVICES PTY., LTD.]2Legacy NDC, 1 package rows20230111_b1a41464-e7d7-640c-e053-2995a90a3f95.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69491-03369491-033-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
ndc (package): 69491-033-01
ndc11 (package): 69491003301
f114a573-ef41-639c-e053-2a95a90a1021b1a41464-e7d7-640c-e053-2995a90a3f952023-01-10WarningsExact identifier
spl id: f114a573-ef41-639c-e053-2a95a90a1021
spl set id: b1a41464-e7d7-640c-e053-2995a90a3f95

Reported adverse events (FAERS/openFDA)#

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