Colgate®

Colgate®
SPL v14
SPL
SPL Set ID b6ca4ec7-5087-4693-82b7-199b44d7f931
Route
DENTAL
Published
Effective Date 2021-11-10
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 Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Saccharin Sodium Sodium Pyrophosphate Cocamidopropyl Betaine Hypromellose, Unspecified Fd&c Blue No. 1 Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2019-10-24 Until 2026-12-30

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, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Saccharin, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide.

Principal Display Panel 170 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

10x

LONGER

LASTING

COOL

MaxFresh®

WITH WHITENING

KNOCKOUT®

FIGHTS BAD BREATH AND

FOOD AFTERTASTES

MINT FUSION®

Recyclable

Tube

NET WT 6.0 OZ (170 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, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Saccharin, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide.

Principal Display Panel 170 G Tube Carton (PRINCIPAL DISPLAY PANEL - 170 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

10x

LONGER

LASTING

COOL

MaxFresh®

WITH WHITENING

KNOCKOUT®

FIGHTS BAD BREATH AND

FOOD AFTERTASTES

MINT FUSION®

Recyclable

Tube

NET WT 6.0 OZ (170 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)