Colgate®

Colgate®
SPL v9
SPL
SPL Set ID 913a2cd6-b6a8-4069-979f-3c696a9bfdf0
Route
DENTAL
Published
Effective Date 2019-12-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Glycerin Hydrated Silica Water Sodium Bicarbonate Polyethylene Glycol 600 Sodium Lauryl Sulfate Sodium Hydroxide Carboxymethylcellulose Sodium, Unspecified Carrageenan Saccharin Sodium Calcium Peroxide Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2011-08-20 Until 2017-12-31
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.

Section 50569-3

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% (0.14% w/v fluoride ion)

Inactive Ingredients

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

Principal Display Panel 130 G Carton

Colgate ®

Fluoride Toothpaste

NET WT 4.6 OZ (130 g)

Baking Soda

& Peroxide

Whitening

Cleans Deep and

Whitens Teeth

Brisk Mint ® Paste

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.

Section 50569-3 (50569-3)

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% (0.14% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

glycerin, hydrated silica, water, sodium bicarbonate, PEG-12, sodium lauryl sulfate, flavor, sodium hydroxide, cellulose gum, carrageenan, sodium saccharin, calcium peroxide, titanium dioxide

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

Colgate ®

Fluoride Toothpaste

NET WT 4.6 OZ (130 g)

Baking Soda

& Peroxide

Whitening

Cleans Deep and

Whitens Teeth

Brisk Mint ® Paste

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:33.065029 · Updated: 2026-03-14T23:12:32.924893