Colgate®

Colgate®
SPL v17
SPL
SPL Set ID 39247381-c565-4e43-8174-f3d9a58b4625
Route
DENTAL
Published
Effective Date 2026-02-27
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 Form Sodium Lauryl Sulfate Saccharin Sodium Titanium Dioxide Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-11-11

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, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

Principal Display Panel 130 G Tube Label

Colgate®

Anticavity Fluoride Toothpaste

cavity

protection

Bubble Fruit®

MINECRAFT

Recyclable

Tube

ADA

Accepted

American

Dental

Association ®

NET WT 4.6 OZ (130 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, titanium dioxide, FD&C blue no. 1, D&C yellow no. 10

Principal Display Panel 130 G Tube Label (PRINCIPAL DISPLAY PANEL - 130 g Tube Label)

Colgate®

Anticavity Fluoride Toothpaste

cavity

protection

Bubble Fruit®

MINECRAFT

Recyclable

Tube

ADA

Accepted

American

Dental

Association ®

NET WT 4.6 OZ (130 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)