Colgate® Total® Advanced Pro-Shield™ Mouthwash Spearmint Surge™

Colgate Total Advanced Pro-Shield Spearmint Surge by

Drug Labeling and Warnings

Colgate Total Advanced Pro-Shield Spearmint Surge 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 SPEARMINT SURGE- 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 Spearmint Surge™

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, sodium saccharin, citric acid, sucralose, FD&C green no. 3, FD&C yellow no. 6

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 - 500 mL 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

SPEARMINT SURGE™

16.9 FL OZ
(1.05 PT)
500 mL

P9892865

PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
COLGATE TOTAL ADVANCED PRO-SHIELD SPEARMINT SURGE 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-721
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)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35000-721-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 35000-721-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 35000-721-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 35000-721-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 35000-721-501.5 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: 79750724-87a5-4eb9-b32d-3676463dde58
Set id: 79c3ee4e-eafb-4714-a310-fe332644d514
Version: 1
Effective Time: 20141210
 
Colgate-Palmolive Company