Colgate Optic White

Manufacturer
Colgate-Palmolive Company
Effective date
2019-12-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:11:48

Label at a glance#

ProductColgate Optic White Icy Fresh Cool Fresh Mint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 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% (0.13% 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 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

propylene glycol, calcium pyrophosphate, glycerin, PEG/PPG-116/66 copolymer, PEG-12, PVP, silica, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, hydrogen peroxide, disodium pyrophosphate, sodium saccharin, sucralose, BHT

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 178 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate®

WHITER TEETH IN 1 WEEK
GOES BEYOND SURFACE STAIN REMOVAL TO DEEPLY WHITEN

ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

NET WT 6.3 OZ (178 g)

OPTIC
WHITE®

ICY FRESH

COOL FRESH MINT

Principal Display Panel - 178 g Tube Label
Principal Display Panel - 178 g Tube Label

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-96135000-961-95, 35000-961-93, 35000-961-92

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
d755401f-38bc-43d0-b483-8ecafb8be6d3ae2f771e-9879-48fc-bb93-43e4eb97e0202019-12-17WarningsExact identifier
spl id: d755401f-38bc-43d0-b483-8ecafb8be6d3
spl set id: ae2f771e-9879-48fc-bb93-43e4eb97e020

Reported adverse events (FAERS/openFDA)#

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