colgate®

Drug Facts

Composition & Product

Active Ingredients

fluoride ion (1.1 mg)

Inactive Ingredients

poloxamer 105 crospovidone, unspecified calcium pyrophosphate peg/ppg-116/66 copolymer hydrogen peroxide silicon dioxide sodium lauryl sulfate sodium pyrophosphate saccharin sodium sodium acid pyrophosphate sucralose butylated hydroxytoluene

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

otc monograph drug completed Since 2021-11-23 Until 2022-12-31

Medication Information

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.

Inactive Ingredients

Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Description

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Questions?

1-800-468-6502

www.colgateopticwhite.com

Use

helps protect against cavities

Section 42229-5

Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022 U.S.A.

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.

Active Ingredients

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Principal Display Panel 59 G Tube Label

Colgate^®

Anticavity Fluoride Toothpaste

OPTIC

WHITE_®

PRO SERIES

REMOVES

15 YEARS

OF STAINS*

5%

HYDROGEN

PEROXIDE

STAIN PREVENTION

NET WT 2.1 OZ (59 g)

Structured Label Content

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.

Inactive Ingredients (Inactive ingredients)

Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.

Questions?

1-800-468-6502

www.colgateopticwhite.com

Use

helps protect against cavities

Section 42229-5 (42229-5)

Dist. by:

COLGATE-PALMOLIVE COMPANY

New York, NY 10022 U.S.A.

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.

Active Ingredients (Active ingredients)

Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)

Principal Display Panel 59 G Tube Label (PRINCIPAL DISPLAY PANEL - 59 g Tube Label)

Colgate^®

Anticavity Fluoride Toothpaste

OPTIC

WHITE_®

PRO SERIES

REMOVES

15 YEARS

OF STAINS*

5%

HYDROGEN

PEROXIDE

STAIN PREVENTION

NET WT 2.1 OZ (59 g)

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "POLOXAMER 105", "unii": "XPP85ZHV76", "classCode": "IACT", "strengthNumerator": "450.3", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "CROSPOVIDONE, UNSPECIFIED", "unii": "2S7830E561", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CALCIUM PYROPHOSPHATE", "unii": "X69NU20D19", "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": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "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": "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": "Dist. by: COLGATE-PALMOLIVE COMPANY New York, NY 10022 U.S.A.", "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 www.colgateopticwhite.com", "Active ingredients": "Sodium Monofluorophosphate 0.76% (0.13% w/v fluoride ion)", "Inactive ingredients": "Poloxamer 105, PVP, Calcium Pyrophosphate, PEG/PPG-116/66 Copolymer, Hydrogen Peroxide (5% w/v), Silica, Flavor, Sodium Lauryl Sulfate, Tetrasodium Pyrophosphate, Sodium Saccharin, Disodium Pyrophosphate, Sucralose, BHT.", "PRINCIPAL DISPLAY PANEL - 59 g Tube Label": "Colgate ® Anticavity Fluoride Toothpaste OPTIC WHITE ® PRO SERIES REMOVES 15 YEARS OF STAINS* 5% HYDROGEN PEROXIDE STAIN PREVENTION NET WT 2.1 OZ (59 g)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information