Colgate®

Colgate®
SPL v5
SPL
SPL Set ID e18060c0-7e03-444c-a5ac-b8ba25ce14ea
Route
DENTAL
Published
Effective Date 2021-11-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Poloxamer 105 Crospovidone, Unspecified Calcium Pyrophosphate Peg/ppg-116/66 Copolymer Hydrogen Peroxide Silicon Dioxide Sodium Lauryl Sulfate Sodium Pyrophosphate Saccharin Sodium Sodium Acid Pyrophosphate Sucralose Butylated Hydroxytoluene

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-11-23 Until 2022-12-31
Description

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Use

helps protect against cavities

Section 42229-5
Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022 U.S.A.
Section 50565-1

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
  • 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.
Questions?

1-800-468-6502

www.colgateopticwhite.com

Active Ingredients

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Inactive Ingredients

Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Principal Display Panel 59 G Tube Label

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF STAINS*

5%

HYDROGEN

PEROXIDE

STAIN PREVENTION

NET WT 2.1 OZ (59 g)

Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)
Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022 U.S.A.
Section 50565-1 (50565-1)

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.

Purpose

Anticavity

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.
Questions?

1-800-468-6502

www.colgateopticwhite.com

Active Ingredients (Active ingredients)

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Principal Display Panel 59 G Tube Label (PRINCIPAL DISPLAY PANEL - 59 g Tube Label)

Colgate®

Anticavity Fluoride Toothpaste

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF STAINS*

5%

HYDROGEN

PEROXIDE

STAIN PREVENTION

NET WT 2.1 OZ (59 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:33.158570 · Updated: 2026-03-14T23:13:13.649161