COLGATE MAX FRESH COOL MINT- 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® Max Fresh® Cool Mint 4.6oz 2in1 Fluoride Toothpaste

Drug Facts

Active ingredient

Sodium fluoride 0.24% (0.14% 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, tetrasodium pyrophosphate, xanthan gum, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label

WITH WHITENING

MaxFresh®

WITH
MINI
BREATH STRIPS

Colgate®
Anticavity Fluoride Toothpaste

Bursting with
Freshness that
Lasts for Hours!

COOL
MINT

NET WT 4.6 OZ (130 g)

PRINCIPAL DISPLAY PANEL - 130 g Bottle Label
COLGATE MAX FRESH COOL MINT 
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-564
Route of Administration DENTAL DEA Schedule     
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) 665.38 mg  in 1 g
WATER (UNII: 059QF0KO0R)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
METHYLCELLULOSE (100 MPA.S) (UNII: 4GFU244C4J)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
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:65954-564-81 130 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 04/06/2008
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 2/2014
Document Id: 11d0b755-0233-46b7-a668-d6a538ec2f24
Set id: 93c443bd-bb73-40a7-bdb0-0d7283220e39
Version: 2
Effective Time: 20140224
 
Mission Hills S.A de C.V