Colgate® Max White® Polar Rush™ Fluoride Toothpaste

Colgate by

Drug Labeling and Warnings

Colgate by is a Otc medication manufactured, distributed, or labeled by Mission Hills, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE  MAX WHITE POLAR RUSH- 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 White® Polar Rush™ 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, D&C red no.33

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 170 g Tube Carton

Colgate®
Anticavity Fluoride Toothpaste

FRESHENS BREATH

Max White®
WITH
MINI
BRIGHT STRIPS

Whitens to Help Teeth Stay Bright*

POLAR RUSH™

NET WT 6.0 OZ (170 g)

Principal Display Panel - 170 g Tube Carton
COLGATE   MAX WHITE POLAR RUSH
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 65954-047
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE2.4 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SORBITOL (UNII: 506T60A25R) 513.26 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)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Product Characteristics
ColorBLUE (DARK BLUE WITH WHITE FILM) Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 65954-047-601 in 1 CARTON12/01/2011
1170 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35512/01/2011
Labeler - Mission Hills, S.A. de C.V. (812312122)

Revised: 4/2019
Document Id: 94d6b58e-f675-44d3-8c8a-83ddeb1d8f0e
Set id: 58339c98-33e3-4b4d-bec6-5c38f74d8c79
Version: 2
Effective Time: 20190411
 
Mission Hills, S.A. de C.V.