Colgate®

Colgate®
SPL v9
SPL
SPL Set ID 0a1389f6-cac9-3d58-0744-c488abb0bbcc
Route
DENTAL
Published
Effective Date 2021-11-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Sorbitol Water Hydrated Silica Polyethylene Glycol 600 Carboxymethylcellulose Sodium, Unspecified Sodium Lauryl Sulfate Saccharin Sodium Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-05-05 Until 2026-12-31
Description

Drug Facts

Purpose

Anticavity

Medication Information

Purpose

Anticavity

Description

Drug Facts

Use

helps protect against cavities

Section 42229-5

Drug Facts

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

Active Ingredient

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.

Principal Display Panel 124 G Tube Label

Colgate®

Anticavity Fluoride Toothpaste

MAXIMUM

cavity

protection*

BUBBLE FRUIT®

ADA

Accepted

American

Dental

Association ®

NET WT

4.4 OZ (124 g)

Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

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

Active Ingredient (Active ingredient)

Sodium Fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.

Principal Display Panel 124 G Tube Label (PRINCIPAL DISPLAY PANEL - 124 g Tube Label)

Colgate®

Anticavity Fluoride Toothpaste

MAXIMUM

cavity

protection*

BUBBLE FRUIT®

ADA

Accepted

American

Dental

Association ®

NET WT

4.4 OZ (124 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:48.518158 · Updated: 2026-03-14T23:14:03.597898