COLGATE MAXFRESH WITH WHITENING KNOCKOUT FLUORIDE- sodium fluoride gel, dentifrice

Colgate MaxFresh with Whitening KnockOut Fluoride by

Drug Labeling and Warnings

Colgate MaxFresh with Whitening KnockOut Fluoride by is a Otc medication manufactured, distributed, or labeled by Team Technologies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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, methylcellulose, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 70 g Tube Carton

Colgate ®

Anticavity Fluoride Toothpaste

NET WT 2.5 OZ (70 g)

MINT FUSION™

NEW

MaxFresh ®

with WHITENING

KnockOut™

WITH ODOR NEUTRALIZING TECHNOLOGY

HELPS DESTROY NASTY ODORS AND

FIGHT LINGERING FOOD AFTERTASTES*

Colgate Max Fresh Knockout

INGREDIENTS AND APPEARANCE

COLGATE MAXFRESH WITH WHITENING KNOCKOUT FLUORIDE 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67659-780(NDC: 65954-780)
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 FORM (UNII: K679OBS311)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue	Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67659-780-58	1 in 1 CARTON	01/05/2016
1		70 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 67659-780-60	1 in 1 CARTON	01/05/2016
2		170 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 final	part355	01/05/2016

Labeler - Team Technologies, Inc. (192339703)

Registrant - Team Technologies, Inc. (192339703)

Establishment
Name	Address	ID/FEI	Business Operations
Team Technologies, Inc.		079337800	relabel(67659-780) , repack(67659-780)