Colgate Optic White High Impact Fluoride

Manufacturer
Team Technologies, Inc
Effective date
2016-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:46:36

Key Label Information

Active Ingredients And Purpose

Active ingredient

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

Purpose

Anticavity

Uses

Use

helps protect against cavities

Warnings

Warnings

Directions And Dosage

Directions

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

Other Label Information

Inactive ingredients

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, phosphoric acid, BHT, water

Questions?

1-800-468-6502

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

Colgate ® OPTIC WHITE ® PLATINUM ™ ANTICAVITY FLUORIDE TOOTHPASTE NET WT 3.0 OZ (85 g) NEW HIGH IMPACT WHITE™ 4 SHADES VISIBLY WHITER* STARTS WORKING IN 3 DAYS ENAMEL SAFE GLISTENING MINT

Label Images

colgate-01
colgate-01

Products

NDC Codes

Ingredients

Complete SPL Sections

SPL UNCLASSIFIED SECTION

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

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

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate ® OPTIC WHITE ® PLATINUM ™ ANTICAVITY FLUORIDE TOOTHPASTE NET WT 3.0 OZ (85 g) NEW HIGH IMPACT WHITE™ 4 SHADES VISIBLY WHITER* STARTS WORKING IN 3 DAYS ENAMEL SAFE GLISTENING MINT

Source Document

Official SPL XML cached by FDA.report · DailyMed PDF

XML object
dailymed/3879d864-c90d-1af0-e054-00144ff88e88/3879d864-c90e-1af0-e054-00144ff88e88.xml
XML SHA-256
de215ae7bdb300738a3688cdff84a64f055663f8f1c8f162b384120a7c5679e0
XML bytes
23816

Legacy File Index

FolderFileDate
otc3879d864-c90e-1af0-e054-00144ff88e88.xml2016-07-25
otccolgate-01.jpg2016-07-25