COLGATE MAXFRESH FRESH 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® One Direction 4.6 oz 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, tetrasodium pyrophosphate, flavor, cocamidopropyl betaine, sodium saccharin, cellulose gum, xanthan gum, mica, titanium dioxide, 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

1D

Colgate®

Fluoride Toothpaste

1D

Fresh Mint

NET WT 4.6 OZ (130g) LIQUID GEL

Principal Display Panel - 130 g Bottle Label
COLGATE MAXFRESH FRESH MINT 
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65954-010
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) 670 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)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
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:65954-010-81 130 g in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part355 01/08/2013
Labeler - Mission Hills S.A de C.V (812312122)

Revised: 2/2014
Document Id: b0f36912-2fc2-4f65-b72c-72255276ec13
Set id: 347c8c99-46e0-4def-8b95-538ea293e1c5
Version: 2
Effective Time: 20140224
 
Mission Hills S.A de C.V