FDA.reportPublic FDA data

Colgate

Manufacturer
Colgate-Palmolive Company | Mission Hills, S.A. de C.V.
Effective date
2026-07-08
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
weekly-update
Hydrated at
2026-07-17 21:44:05

Key Label Information#

Active Ingredients And Purpose

Active ingredient

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Anticavity

Uses

Use

helps protect against cavities

Warnings

Warnings

Directions And Dosage

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

Other Label Information

Inactive ingredients

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

Questions?

1-800-468-6502

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

Colgate ® Anticavity Fluoride Toothpaste cavity protection Bubble Fruit ® ADA Accepted American Dental Association ® Recyclable Tube NET WT 4.6 OZ (130 g)

Label Images#

colgate-01
colgate-01

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35000-95035000-950-46

Ingredients#

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
POLYETHYLENE GLYCOL 600NL4J9F21N9IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM LAURYL SULFATE368GB5141JIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C YELLOW NO. 1035SW5USQ3GIACT

Complete SPL Sections#

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Directions

DOSAGE & ADMINISTRATION SECTION

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 INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-468-6502

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Dist. by: COLGATE-PALMOLIVE CO. New York, NY 10022 U.S.A.

PRINCIPAL DISPLAY PANEL - 130 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Colgate ® Anticavity Fluoride Toothpaste cavity protection Bubble Fruit ® ADA Accepted American Dental Association ® Recyclable Tube NET WT 4.6 OZ (130 g)

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52021-12-06full-release2026-06-01 00:44:22