COLGATE MAX FRESH COOL MINT- sodium fluoride gel, dentifrice 
Mission Hills S.A de C.V

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Colgate® Max Fresh® Cool Mint 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 olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician
children 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)
children under 2 yearsask a dentist or physician

Inactive ingredients

sorbitol, water, hydrated silica, PEG-12, sodium lauryl sulfate, flavor, cellulose gum, tetrasodium pyrophosphate, cocamidopropyl betaine, sodium saccharin, methylcellulose, FD&C blue no. 1

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity
Fluoride Toothpaste

NET WT 6.0 OZ (170 g)

COOL MINT

Max Fresh®
with WHITENING

BREATH STRIPS

FRESHNESS THAT LASTS FOR HOURS!

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton
COLGATE  MAX FRESH COOL MINT
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65954-014
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.1 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorPEPPERMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65954-014-601 in 1 CARTON08/01/201112/31/2022
1170 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:65954-014-011 in 1 CARTON08/01/2011
228.3 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:65954-014-751 in 1 CARTON08/01/201112/31/2018
379 g in 1 TUBE; Type 0: Not a Combination Product
4NDC:65954-014-781 in 1 CARTON08/01/201112/31/2016
4221 g in 1 TUBE; Type 0: Not a Combination Product
5NDC:65954-014-991 in 1 CARTON08/01/2011
553 g in 1 TUBE; Type 0: Not a Combination Product
6NDC:65954-014-581 in 1 CARTON08/01/2011
670 g in 1 TUBE; Type 0: Not a Combination Product
7NDC:65954-014-631 in 1 CARTON06/07/202212/31/2024
7178 g in 1 TUBE; Type 0: Not a Combination Product
8NDC:65954-014-951 in 1 CARTON05/28/2024
8178 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH DRUGM02108/01/2011
Labeler - Mission Hills S.A de C.V (812312122)
Registrant - Colgate-Palmolive Company (001344381)

Revised: 4/2019
Document Id: 6f04db7b-c705-4038-8a35-cd8a62b4bd81
Set id: d142e43f-415a-41c5-a7db-8b18a039a323
Version: 16
Effective Time: 20190409
 
Mission Hills S.A de C.V