Colgate® Total® Advanced Pro-Shield™ Mouthwash Wintermint Rush™

Colgate Total Advanced Pro-Shield Wintermint Rush by

Drug Labeling and Warnings

Colgate Total Advanced Pro-Shield Wintermint Rush by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE TOTAL ADVANCED PRO-SHIELD WINTERMINT RUSH- cetylpyridinium chloride 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® Advanced Pro-Shield™ Mouthwash Wintermint Rush™

Drug Facts

Active ingredient

Cetylpyridinium chloride 0.075%

Purpose

Antigingivitis/antiplaque

Uses

helps prevent and reduce plaque and gingivitis

Warnings

Ask a dentist if condition persists or worsens after regular use.

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

adults and children 12 years of age and olderrinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day. Do not swallow.
children 6 years to under 12 years of agesupervise use
children under 6 years of agedo not use

Inactive ingredients

water, glycerin, propylene glycol, sorbitol, poloxamer 407, flavor, potassium sorbate, citric acid, sodium saccharin, FD&C green no. 3, D&C red no. 33

Other Information

  • this rinse is not intended to replace brushing or flossing
  • store at 59°F to 77°F
  • keep from freezing

Questions?

1-800-468-6502

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

PRINCIPAL DISPLAY PANEL - 1 L Bottle Label

ALCOHOL FREE

Colgate®

Antigingivitis/Antiplaque Mouthwash

Total®

ADVANCED
PRO-SHIELD™

12-HR Protection Against Germs*

  • ✓ KILLS 99% OF GERMS ON CONTACT
  • ✓ SIGNIFICANTLY REDUCES PLAQUE
  • ✓ HELPS PREVENT GINGIVITIS
  • ✓ NO BURN OF ALCOHOL
  • ✓ FRESHENS BREATH

    • WINTERMINT RUSH™

    33.8 FL OZ
    (1.05 QT)
    1 L

    P9892867

    Principal Display Panel - 1 L Bottle Label
    COLGATE TOTAL ADVANCED PRO-SHIELD WINTERMINT RUSH 
    cetylpyridinium chloride rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-722
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetylpyridinium chloride (UNII: D9OM4SK49P) (Cetylpyridinium - UNII:CUB7JI0JV3) Cetylpyridinium chloride15 mg  in 20 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    Product Characteristics
    ColorPURPLEScore    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 35000-722-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC: 35000-722-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC: 35000-722-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35605/06/2013
    Labeler - Colgate-Palmolive Company (068693167)

    Revised: 12/2014
    Document Id: b154088e-a38e-4665-9e23-c14af46f02a8
    Set id: 23b11a15-a38b-408d-802e-5d5ec67c36cb
    Version: 1
    Effective Time: 20141210