COLGATE MAXFRESH CHARCOAL- sodium fluoride gel, dentifrice

Colgate MaxFresh Charcoal by

Drug Labeling and Warnings

Colgate MaxFresh Charcoal 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, Flavor, Sodium Lauryl Sulfate, Cellulose Gum, Sodium Saccharin, Tetrasodium Pyrophosphate, Cocamidopropyl Betaine, Hydroxypropyl Methylcellulose, Blue 1, Charcoal Powder, Red 40, 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 - Two 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

Recyclable
Tube

CHARCOAL MINT

2
VALUE
PACK

10X
LONGER
LASTING
COOL†

MaxFresh®
WITH WHITENING
+ CHARCOAL

CHARCOAL MINT

TWO 6.0 OZ (170 g) TUBES TOTAL NET WT 12 OZ (340 g)

INGREDIENTS AND APPEARANCE

COLGATE MAXFRESH CHARCOAL 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 35000-990
Route of Administration	DENTAL

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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
ACTIVATED CHARCOAL (UNII: 2P3VWU3H10)
FD&C RED NO. 40 (UNII: WZB9127XOA)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 35000-990-99	1 in 1 CARTON	10/01/2020
1		53.8 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 35000-990-58	1 in 1 CARTON	10/01/2020
2		70.8 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 35000-990-60	1 in 1 CARTON	10/24/2020
3		170 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 35000-990-34	2 in 1 CARTON	11/16/2020
4		170 g in 1 TUBE; Type 0: Not a Combination Product
5	NDC: 35000-990-95	1 in 1 CARTON	01/29/2021
5		178 g in 1 TUBE; Type 0: Not a Combination Product
6	NDC: 35000-990-69	1 in 1 CARTON	06/17/2024
6		113 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	10/01/2020

Labeler - Colgate-Palmolive Company (001344381)