COLGATE MAX FRESH ADVANCED WHITENING- sodium fluoride gel, dentifrice

Colgate Max Fresh by

Drug Labeling and Warnings

Colgate Max Fresh by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Mission Hills, S.A. de C.V.. 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 the 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 - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

10X
LONGER LASTING
COOL†

Max Fresh®
ADVANCED WHITENING

EXTRA WHITENING POWER‡

NET WT 6.0 OZ (170 g)

CLEAN MINT

INGREDIENTS AND APPEARANCE

COLGATE MAX FRESH  ADVANCED WHITENING
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-899
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	2.4 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 SODIUM, UNSPECIFIED (UNII: K679OBS311)
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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	BLUE (LIGHT BLUE WITH WHITE FILM)	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-899-60	1 in 1 CARTON	10/16/2021	12/31/2024
1		170 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-899-95	1 in 1 CARTON	10/16/2021
2		178 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-899-34	2 in 1 CARTON	10/16/2021	12/31/2024
3		170 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-899-58	1 in 1 CARTON	07/30/2022
4		70.87 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-899-78	1 in 1 CARTON	01/01/2024
5		70.8 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	10/16/2021

Labeler - Colgate-Palmolive Company (001344381)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Hills, S.A. de C.V.		812312122	MANUFACTURE(35000-899) , ANALYSIS(35000-899) , PACK(35000-899) , LABEL(35000-899)