Colgate® - DailyMed Details

Colgate®

SPL v9

SPL

SPL Set ID 5bc0b430-6f68-4e52-a1da-de19136eaeac

Route

DENTAL

Published

Effective Date 2023-01-31

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (7.6 mg)

Inactive Ingredients

Dibasic Calcium Phosphate Dihydrate Water Sorbitol Sodium Lauryl Sulfate Carboxymethylcellulose Sodium, Unspecified Sodium Pyrophosphate Saccharin Sodium

Identifiers & Packaging

Pill Appearance

Color: white

Marketing Status

OTC MONOGRAPH DRUG Active Since 2009-06-04

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 the 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

Active Ingredient

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

Inactive Ingredients

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions Or Comments?

Call toll-free 1-800-468-6502

Principal Display Panel 5 G Tube Label

P1536526_E

Colgate^®

Anticavity Toothpaste

Cavity

Protection

NET WT 5g(0.17 oz)

2

HDPE

Principal Display Panel 10 G Tube Label

P1536525

Colgate^®

Anticavity Toothpaste

Cavity

Protection

NET WT 10g(0.35 OZ)

2

HDPE

Structured Label Content

Use

helps protect against cavities

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of the 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

Active Ingredient (Active ingredient)

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

Inactive Ingredients (Inactive ingredients)

dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin

Questions Or Comments? (Questions or comments?)

Call toll-free 1-800-468-6502

Principal Display Panel 5 G Tube Label (PRINCIPAL DISPLAY PANEL - 5 g Tube Label)

P1536526_E

Colgate^®

Anticavity Toothpaste

Cavity

Protection

NET WT 5g(0.17 oz)

2

HDPE

Principal Display Panel 10 G Tube Label (PRINCIPAL DISPLAY PANEL - 10 g Tube Label)

P1536525

Colgate^®

Anticavity Toothpaste

Cavity

Protection

NET WT 10g(0.35 OZ)

2

HDPE

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "7.6", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "DIBASIC CALCIUM PHOSPHATE DIHYDRATE", "unii": "O7TSZ97GEP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "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": ""}]

Raw Label Data

All Sections (JSON)

{"Use": "helps protect against cavities", "42229-5": "Drug Facts", "50565-1": "Keep out of the 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", "Active ingredient": "Sodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)", "Inactive ingredients": "dicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, sodium saccharin", "Questions or comments?": "Call toll-free 1-800-468-6502", "PRINCIPAL DISPLAY PANEL - 5 g Tube Label": "P1536526_E Colgate ® Anticavity Toothpaste Cavity Protection NET WT 5g(0.17 oz) 2 HDPE", "PRINCIPAL DISPLAY PANEL - 10 g Tube Label": "P1536525 Colgate ® Anticavity Toothpaste Cavity Protection NET WT 10g(0.35 OZ) 2 HDPE"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:40.873721 · Updated: 2026-03-14T23:05:35.877028