Colgate Optic White Beauty Radiant

Manufacturer
Mission Hills S.A de C.V
Effective date
2019-04-18
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:25:30

Label at a glance#

ProductColgate Optic White Beauty Radiant
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure10 sections

Dosage and administration

adults and children 6 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 6 to 12 years: instruct in good brushing and rinsing habits (to minimize swallowing) children under 6 years: do not use unless directed by a dentist or physician

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 1.14% (0.19% 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 6 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 6 to 12 years: instruct in good brushing and rinsing habits (to minimize swallowing)
  • children under 6 years: do not use unless directed by a dentist or physician

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Some people may experience tooth sensitivity or gum discomfort when using whitening products. This discomfort is temporary and not harmful. If you experience more than mild tooth sensitivity, stop use and consult your dentist.

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RADIANT™

WHITENS INSIDE & OUT
FOR A RADIANT SMILE

Colgate®

OPTIC
WHITE
BEAUTY™

ANTICAVITY FLUORIDE TOOTHPASTE
ENAMEL SAFE
ICY MINT

NET WT 3.0 OZ (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label
PRINCIPAL DISPLAY PANEL - 85 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
65954-40065954-400-63, 65954-400-16

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
8f26abde-80bf-47a8-b0fa-333c7e0e6418664b0168-5e28-4bc9-b8e0-b7019c4aa8552019-04-18WarningsExact identifier
spl id: 8f26abde-80bf-47a8-b0fa-333c7e0e6418
spl set id: 664b0168-5e28-4bc9-b8e0-b7019c4aa855

Reported adverse events (FAERS/openFDA)#

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