Colgate®

Colgate®
SPL v5
SPL
SPL Set ID f6a0ffb4-2149-44d8-adf6-aea9bc9608ff
Route
DENTAL
Published
Effective Date 2019-04-05
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

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-03-12
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, mica, titanium dioxide, D&C yellow no. 10, FD&C blue no. 1

Principal Display Panel 130 G Tube Label

Colgate ®

Fluoride Toothpaste

CLINICALLY PROVEN

Cavity & Enamel Protection

ILLUMINATION

ENTERTAINMENT

minions ™

ADA

Accepted

American

Dental

Association ®

Toothpaste

NET WT

4.6 OZ

(130 g)

Mild BUBBLE FRUIT®

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

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

Colgate ®

Fluoride Toothpaste

CLINICALLY PROVEN

Cavity & Enamel Protection

ILLUMINATION

ENTERTAINMENT

minions ™

ADA

Accepted

American

Dental

Association ®

Toothpaste

NET WT

4.6 OZ

(130 g)

Mild BUBBLE FRUIT®

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:52.745121 · Updated: 2026-03-14T23:05:59.331876