colgate®

colgate®
SPL v1
SPL
SPL Set ID a48e83ae-a02a-4a6d-a601-7acaba3bbbc9
Route
dental
Published
Effective Date 2025-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
fluoride ion (11.4 mg)
Inactive Ingredients
propylene glycol calcium pyrophosphate peg/ppg-116/66 copolymer water hydrogen peroxide povidone k30 hydrated silica sodium lauryl sulfate sodium pyrophosphate saccharin sodium sodium acid pyrophosphate sucralose butylated hydroxytoluene

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-11-24

Purpose

Anticavity

Description

Drug Facts


Medication Information

Purpose

Anticavity

Directions
adults and children 6 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 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 6 years do not use unless directed by a dentist or physician
Inactive Ingredients

Propylene Glycol, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Water, Hydrogen Peroxide (5% w/v), PVP, Silica, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Flavor, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

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. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Contol Center right away.

Active Ingredient

Sodium Monofluorophosphate 1.14% (0.18% w/v fluoride ion)

Principal Display Panel 85 G Tube Carton

Colgate®

Anticavity Fluoride Toothpaste

2

VALUE

PACK

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF DEEP-SET STAINS*

ACTIVSHINE

TECHNOLOGY

5%

HYDROGEN

PEROXIDE

ENAMEL RENEWAL

PASTE

SOOTHING MINT

TWO 3.0 OZ (85 g) TUBES • TOTAL NET WT 6.0 OZ (170 g)

ENAMEL SAFE


Structured Label Content

Purpose

Anticavity

Directions
adults and children 6 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 6 to 12 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 6 years do not use unless directed by a dentist or physician
Inactive Ingredients (Inactive ingredients)

Propylene Glycol, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Water, Hydrogen Peroxide (5% w/v), PVP, Silica, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Flavor, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

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. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Contol Center right away.

Active Ingredient (Active ingredient)

Sodium Monofluorophosphate 1.14% (0.18% w/v fluoride ion)

Principal Display Panel 85 G Tube Carton (PRINCIPAL DISPLAY PANEL - 85 g Tube Carton)

Colgate®

Anticavity Fluoride Toothpaste

2

VALUE

PACK

OPTIC

WHITE®

PRO SERIES

REMOVES

15 YEARS

OF DEEP-SET STAINS*

ACTIVSHINE

TECHNOLOGY

5%

HYDROGEN

PEROXIDE

ENAMEL RENEWAL

PASTE

SOOTHING MINT

TWO 3.0 OZ (85 g) TUBES • TOTAL NET WT 6.0 OZ (170 g)

ENAMEL SAFE


Advanced Ingredient Data


Raw Label Data

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