Colgate®

Colgate®
SPL v5
SPL
SPL Set ID 202c6c62-e16a-4716-babe-d5414006c79e
Route
DENTAL
Published
Effective Date 2025-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Dibasic Calcium Phosphate Dihydrate Water Glycerin Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Sodium Pyrophosphate Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-22

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 Monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Inactive Ingredients

Dicalcium Phosphate Dihydrate, Water, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Tetrasodium Pyrophosphate, Sodium Saccharin.

Principal Display Panel 226 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

Cavity

Protection

NET WT 8.0 OZ (226 g)

ADA

Accepted

American

Dental

Association ®

Strengthens Teeth

with Active Fluoride

Great Regular Flavor


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 Monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Dicalcium Phosphate Dihydrate, Water, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Tetrasodium Pyrophosphate, Sodium Saccharin.

Principal Display Panel 226 G Tube Carton (PRINCIPAL DISPLAY PANEL - 226 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

Cavity

Protection

NET WT 8.0 OZ (226 g)

ADA

Accepted

American

Dental

Association ®

Strengthens Teeth

with Active Fluoride

Great Regular Flavor


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)