Colgate® MaxFresh® with Whitening KnockOut™ Fluoride Toothpaste

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 Mission Hills S.A de C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE MAXFRESH WITH WHITENING KNOCKOUT FLUORIDE- sodium fluoride gel, dentifrice 
Mission Hills S.A de C.V

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Colgate® MaxFresh® with Whitening KnockOut™ Fluoride Toothpaste

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

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 MAXFRESH WITH WHITENING KNOCKOUT FLUORIDE 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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: 65954-780-58	1 in 1 CARTON	01/05/2016
1		70 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 65954-780-60	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 - Mission Hills S.A de C.V (812312122)

Revised: 4/2019

Document Id: b74b7d70-909d-4526-85d0-ffb7f6e74e54

34390-5

Set id: 8fa5d5a6-66ba-4351-bd6b-b5cc1d72d634

Version: 2

Effective Time: 20190418

 

Mission Hills S.A de C.V