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 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 or comments?

Call toll-free 1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Bursting with Freshness That Lasts for Hours

Colgate®
Fluoride Toothpaste

MaxFresh®
WITH
MINI BREATH STRIPS

WHITENING

COOL MINT

NET WT 6.0 OZ (170 g)

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 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) 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 (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
1 170 g in 1 TUBE
2 NDC:65954-014-01 1 in 1 CARTON
2 28.3 g in 1 TUBE
3 NDC:65954-014-75 1 in 1 CARTON
3 79 g in 1 TUBE
4 NDC:65954-014-78 1 in 1 CARTON
4 221 g in 1 TUBE
5 NDC:65954-014-99 1 in 1 CARTON
5 53 g in 1 TUBE
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: 7/2013
Document Id: e42ecebb-8634-4d73-adf4-a4244a804b7b
Set id: d142e43f-415a-41c5-a7db-8b18a039a323
Version: 5
Effective Time: 20130710
 
Mission Hills S.A de C.V