colgate®

colgate®
SPL v11
SPL
SPL Set ID 40fa39f5-27a0-4d36-ad0a-fb2931e4b117
Route
dental
Published
Effective Date 2019-04-03
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 2015-12-31
Purpose

Anticavity

Description

Drug Facts

Medication Information

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
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

Description

Drug Facts

Questions?

1-800-468-6502

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.

Active Ingredient

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

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

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
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

Questions?

1-800-468-6502

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.

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.14% w/v fluoride ion)

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: 2026-02-15T12:04:36.054289 · Updated: 2026-03-14T23:05:28.061539