Colgate® Total® Lasting White™ Polar Freshmint

Colgate Total Lasting White Polar Freshmint by

Drug Labeling and Warnings

Colgate Total Lasting White Polar Freshmint by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE TOTAL LASTING WHITE POLAR FRESHMINT- sodium fluoride rinse 
Colgate-Palmolive Company

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® Total® Lasting White™ Polar Freshmint

Drug Facts

Active ingredient

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

Anticavity

Use

aids in the prevention of dental cavities

Warnings

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision

Children under 6 years of age: consult a dentist or doctor

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, sodium acrylates/methacryloylethyl phosphate copolymer, phosphoric acid, poloxamer 338, poloxamer 407, flavor, PEG-40 castor oil, sodiumsaccharin, disodiumphosphate, potassiumsorbate, sodiumlauryl sulfate, sucralose

Other Information

Store at controlled room temperature 68 – 77° F (20 – 25°C)

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 250 mL Bottle Label

NEW

ALCOHOL FREE

Colgate®
Anticavity Fluoride Mouthwash

Total®

LASTING WHITE™

Strengthens Teeth &
Helps Protect Against Stains

  • ✓ Re-mineralizes & strengthens enamel
  • ✓ Helps prevent cavities
  • ✓ Fights tartar
  • ✓ Freshens breath
  • ✓ No burn of alcohol

POLAR FRESHMINT

IMPORTANT:
Read directions
for proper use

8.4 FL OZ
(250 mL)

P9895507

Principal Display Panel - 250 mL Bottle Label
COLGATE TOTAL LASTING WHITE POLAR FRESHMINT 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-724
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SORBITOL (UNII: 506T60A25R)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
POTASSIUM PYROPHOSPHATE (UNII: B9W4019H5G)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
BUTYL ESTER OF METHYL VINYL ETHER/MALEIC ANHYDRIDE COPOLYMER (125000 MW) (UNII: 389H2R62BD)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35000-724-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 35000-724-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 35000-724-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 35000-724-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35508/01/2014
Labeler - Colgate-Palmolive Company (068693167)

Revised: 12/2015
Document Id: d6748403-43db-4f66-8ae3-5c5e2565e18b
Set id: 3d8e4d17-8bfb-46c5-a564-7bce4f9932e9
Version: 2
Effective Time: 20151202
 
Colgate-Palmolive Company