Colgate®

Colgate®
SPL v8
SPL
SPL Set ID 56b96f8f-4f75-4762-ae2c-4064543e46d8
Route
DENTAL
Published
Effective Date 2019-04-08
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 Fd&c Blue No. 1 D&c Yellow No. 10

Identifiers & Packaging

Pill Appearance
Color: green
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2013-03-01 Until 2020-12-31
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.

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

Principal Display Panel 130 G Tube Carton

Colgate®

Fluoride Toothpaste

Baking Soda

SPARKLING

WHITE ®

Whitens & Helps Protect

Teeth from Stains

Mint Zing

gel

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

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

Colgate®

Fluoride Toothpaste

Baking Soda

SPARKLING

WHITE ®

Whitens & Helps Protect

Teeth from Stains

Mint Zing

gel

NET WT 4.6 OZ (130 g)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:32.376951 · Updated: 2026-03-14T23:05:21.514130