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.

----------

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 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, 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 Type HUMAN OTC DRUG Item Code (Source) NDC:65954-014
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) 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 FORM (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
Color BLUE Score     
Shape Size
Flavor PEPPERMINT Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65954-014-60 1 in 1 CARTON 08/01/2011
1 170 g in 1 TUBE; Type 0: Not a Combination Product
2 NDC:65954-014-01 1 in 1 CARTON 08/01/2011
2 28.3 g in 1 TUBE; Type 0: Not a Combination Product
3 NDC:65954-014-75 1 in 1 CARTON 08/01/2011
3 79 g in 1 TUBE; Type 0: Not a Combination Product
4 NDC:65954-014-78 1 in 1 CARTON 08/01/2011
4 221 g in 1 TUBE; Type 0: Not a Combination Product
5 NDC:65954-014-99 1 in 1 CARTON 08/01/2011
5 53 g in 1 TUBE; Type 0: Not a Combination Product
6 NDC:65954-014-58 1 in 1 CARTON 08/01/2011
6 70 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 08/01/2011
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 8/2016
Document Id: bc6f83cc-b8b6-4a33-ac14-f55a243bc692
Set id: d142e43f-415a-41c5-a7db-8b18a039a323
Version: 7
Effective Time: 20160826
 
Mission Hills S.A de C.V