Colgate®

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1 mg)

Inactive Ingredients

Propylene Glycol Calcium Pyrophosphate Povidone K15 Peg/ppg-116/66 Copolymer Hydrogen Peroxide Sodium Lauryl Sulfate Sodium Pyrophosphate Saccharin Sodium Sodium Acid Pyrophosphate Silicon Dioxide Sucralose Butylated Hydroxytoluene

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2022-01-07 Until 2024-12-31

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% (0.12% w/v fluoride ion)

Inactive Ingredients

Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (3% w/v), Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Disodium Pyrophosphate, Sodium Saccharin, Silica, Sucralose, BHT.

Principal Display Panel 121 G Tube Carton

Colgate^®

Anticavity Fluoride Toothpaste

OPTIC

WHITE_®

RENEWAL

10x

WHITER TEETH*

3%

HYDROGEN

PEROXIDE

STAIN PREVENTION

NET WT 4.3 OZ (121 g)

ENAMEL SAFE

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% (0.12% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (3% w/v), Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Disodium Pyrophosphate, Sodium Saccharin, Silica, Sucralose, BHT.

Principal Display Panel 121 G Tube Carton (PRINCIPAL DISPLAY PANEL - 121 g Tube Carton)

Colgate^®

Anticavity Fluoride Toothpaste

OPTIC

WHITE_®

RENEWAL

10x

WHITER TEETH*

3%

HYDROGEN

PEROXIDE

STAIN PREVENTION

NET WT 4.3 OZ (121 g)

ENAMEL SAFE

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "527", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CALCIUM PYROPHOSPHATE", "unii": "X69NU20D19", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K15", "unii": "E54VE15114", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PEG/PPG-116/66 COPOLYMER", "unii": "JP0CK963E0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROGEN PEROXIDE", "unii": "BBX060AN9V", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM PYROPHOSPHATE", "unii": "O352864B8Z", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM ACID PYROPHOSPHATE", "unii": "H5WVD9LZUD", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "BUTYLATED HYDROXYTOLUENE", "unii": "1P9D0Z171K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "helps protect against cavities", "42229-5": "Drug Facts", "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": "Sodium Monofluorophosphate 0.76% (0.12% w/v fluoride ion)", "Inactive ingredients": "Propylene Glycol, Calcium Pyrophosphate, PVP, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (3% w/v), Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Disodium Pyrophosphate, Sodium Saccharin, Silica, Sucralose, BHT.", "PRINCIPAL DISPLAY PANEL - 121 g Tube Carton": "Colgate ® Anticavity Fluoride Toothpaste OPTIC WHITE ® RENEWAL 10x WHITER TEETH* 3% HYDROGEN PEROXIDE STAIN PREVENTION NET WT 4.3 OZ (121 g) ENAMEL SAFE"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information