Colgate® - DailyMed Details

Colgate®

SPL v3

SPL

SPL Set ID c44c7a7e-fc3e-a81b-1961-ff89614b678f

Route

DENTAL

Published

Effective Date 2021-02-05

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Fluoride Ion (1.1 mg)

Inactive Ingredients

Sorbitol Water Hydrated Silica Polyethylene Glycol 600 Carboxymethylcellulose Sodium, Unspecified Sodium Lauryl Sulfate Saccharin Sodium D&c Yellow No. 10 Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance

Color: green

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-02-22

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	ask a dentist or physician

Questions?

1-800-468-6502

Active Ingredient

Sodium Fluoride

0.24% (0.15% w/v fluoride ion)

Inactive Ingredients

Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.

Principal Display Panel 124 G Tube Label

Colgate^®

Anticavity Fluoride Toothpaste

KIDS

MAXIMUM

cavity

protection*

ages

6+

bubble

fruit^®

★
sugar free
★
paraben free
★
no artificial

preservatives

ADA

Accepted

American

Dental

Association

®

NET WT 4.4 OZ (124 g)

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 Fluoride

0.24% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.

Principal Display Panel 124 G Tube Label (PRINCIPAL DISPLAY PANEL - 124 g Tube Label)

Colgate^®

Anticavity Fluoride Toothpaste

KIDS

MAXIMUM

cavity

protection*

ages

6+

bubble

fruit^®

★
sugar free
★
paraben free
★
no artificial

preservatives

ADA

Accepted

American

Dental

Association

®

NET WT 4.4 OZ (124 g)

Advanced Ingredient Data

[{"name": "FLUORIDE ION", "unii": "Q80VPU408O", "classCode": "ACTIM", "strengthNumerator": "1.1", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "476", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDRATED SILICA", "unii": "Y6O7T4G8P9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYETHYLENE GLYCOL 600", "unii": "NL4J9F21N9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED", "unii": "K679OBS311", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM LAURYL SULFATE", "unii": "368GB5141J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SACCHARIN SODIUM", "unii": "SB8ZUX40TY", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C BLUE NO. 1", "unii": "H3R47K3TBD", "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 Fluoride 0.24% (0.15% w/v fluoride ion)", "Inactive ingredients": "Sorbitol, Water, Hydrated Silica, PEG-12, Cellulose Gum, Sodium Lauryl Sulfate, Flavor, Sodium Saccharin, Blue 1, Yellow 10.", "PRINCIPAL DISPLAY PANEL - 124 g Tube Label": "Colgate ® Anticavity Fluoride Toothpaste KIDS MAXIMUM cavity protection* ages 6+ bubble fruit ® ★ sugar free ★ paraben free ★ no artificial preservatives ADA Accepted American Dental Association ® NET WT 4.4 OZ (124 g)"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:48.527030 · Updated: 2026-03-14T23:02:33.495898