Colgate®

Colgate®
SPL v2
SPL
SPL Set ID c6522b2b-bda0-4263-a1bb-5249dcb6e1bf
Route
DENTAL
Published
Effective Date 2013-01-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1 mg)
Inactive Ingredients
Calcium Pyrophosphate Propylene Glycol Peg/ppg-116/66 Copolymer Polyethylene Glycol 600 Glycerin Povidone K15 Sodium Lauryl Sulfate Sodium Pyrophosphate Silicon Dioxide Hydrogen Peroxide Saccharin Sodium Phosphoric Acid Sucralose Butylated Hydroxytoluene Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-01-02

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 as a dentist or physician
Questions?

1-800-468-6502

Active Ingredient

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Inactive Ingredients

calcium pyrophosphate, propylene glycol, PEG/PPG 116/66 copolymer, PEG-12, glycerin, PVP, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, silica, hydrogen peroxide, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water

Principal Display Panel 156 G Tube Carton Label

Colgate ®

WHITER TEETH IN ONE WEEK

OPTIC

WHITE®

DAILY ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

NET WT 5.5 OZ (156 g)

COOL MILD MINT


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 as a dentist or physician
Questions?

1-800-468-6502

Active Ingredient (Active ingredient)

Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

calcium pyrophosphate, propylene glycol, PEG/PPG 116/66 copolymer, PEG-12, glycerin, PVP, flavor, sodium lauryl sulfate, tetrasodium pyrophosphate, silica, hydrogen peroxide, sodium saccharin, phosphoric acid, sucralose, butylated hydroxytoluene, water

Principal Display Panel 156 G Tube Carton Label (PRINCIPAL DISPLAY PANEL - 156 g Tube Carton Label)

Colgate ®

WHITER TEETH IN ONE WEEK

OPTIC

WHITE®

DAILY ANTICAVITY FLUORIDE TOOTHPASTE | ENAMEL SAFE

NET WT 5.5 OZ (156 g)

COOL MILD MINT


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)