COLGATE MAX FRESH CLEAN MINT- sodium fluoride gel, dentifrice

Colgate by

Drug Labeling and Warnings

Colgate by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

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

Purpose

Anticavity

Use

helps protect against cavities

Warnings

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

Inactive ingredients

Sorbitol, Water, Hydrated Silica, PEG-12, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Sodium Saccharin, Hydroxypropyl Methylcellulose, Blue 1, Titanium Dioxide, Yellow 5.

Questions?

1-800-468-6502

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 70 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

NET WT 2.5 OZ (70.0 g)

10X
LONGER
LASTING
COOL†

Max Fresh®
WITH WHITENING
BREATH STRIPS

CLEAN MINT

INGREDIENTS AND APPEARANCE

COLGATE  MAX FRESH CLEAN MINT
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65954-831
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	1.1 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)	564.38 mg  in 1 g
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	BLUE	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65954-831-58	1 in 1 CARTON	05/28/2024
1		70 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65954-831-95	1 in 1 CARTON	06/17/2024
2		179 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M021	05/28/2024

Labeler - Colgate-Palmolive Company (812312122)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Hills, S.A. de C.V.		812312122	ANALYSIS(65954-831) , MANUFACTURE(65954-831) , PACK(65954-831) , LABEL(65954-831)