Colgate Optic White Stain Prevention

Manufacturer
Colgate-Palmolive Company | Mission Hills, S.A. de C.V.
Effective date
2024-10-17
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:43:35

Label at a glance#

ProductColgate Optic White Stain Prevention
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76% (0.12% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (3% w/v), Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Disodium Pyrophosphate, Sodium Saccharin, Silica, Sucralose, BHT.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

Dist. by:
COLGATE-PALMOLIVE COMPANY
New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 121 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®
Anticavity Fluoride Toothpaste

OPTIC
WHITE®
RENEWAL

10x
WHITER TEETH*

3%
HYDROGEN
PEROXIDE

STAIN PREVENTION

NET WT 4.3 OZ (121 g)
ENAMEL SAFE

Principal Display Panel - 121 g Tube Carton
Principal Display Panel - 121 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35000-893-41Colgate Optic White Stain Prevention116 g in 1 TUBEPASTE, DENTIFRICE1164
35000-893-41Colgate Optic White Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE14
35000-893-43Colgate Optic White Stain Prevention121 g in 1 TUBEPASTE, DENTIFRICE1214
35000-893-43Colgate Optic White Stain Prevention1 in 1 CARTONPASTE, DENTIFRICE14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35000-893COLGATE OPTIC WHITE STAIN PREVENTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [COLGATE-PALMOLIVE COMPANY]4Legacy NDC, 4 package rows20241215_d1350584-31cc-4cfb-bfcd-b07ff7e087d0.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-89335000-893-43, 35000-893-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8dc87f0b-e5e8-4f40-bcaf-01be95ae9138d1350584-31cc-4cfb-bfcd-b07ff7e087d02024-10-17WarningsExact identifier
spl id: 8dc87f0b-e5e8-4f40-bcaf-01be95ae9138
spl set id: d1350584-31cc-4cfb-bfcd-b07ff7e087d0

Reported adverse events (FAERS/openFDA)#

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