Colgate® Total® 12Hr Pro-Shield® Peppermint Blast®

Colgate Total 12Hr Pro-Shield Peppermint Blast by

Drug Labeling and Warnings

Colgate Total 12Hr Pro-Shield Peppermint Blast by is a Otc medication manufactured, distributed, or labeled by Colgate-Palmolive Company, Kleen Test Products Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COLGATE TOTAL 12HR PRO-SHIELD PEPPERMINT BLAST- 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.

----------

Colgate® Total® 12Hr Pro-Shield® Peppermint Blast®

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 blue no. 1

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 - 1.5 L Bottle Label

50% MORE FREE
vs 33.8 FL OZ

Colgate®
Antigingivitis
Antiplaque Mouthwash

ALCOHOL FREE

Total®

12 HR PRO-SHIELD*®

Germ Protection Even After Eating and Drinking

  • ✓ Kills 99% of Germs on Contact
  • ✓ Significantly Reduces Plaque
  • ✓ Helps Prevent Gingivitis
  • ✓ No Burn of Alcohol

PEPPERMINT BLAST®

50.7 FL OZ
(1.58 QT)
1.5 L

P9903753

PRINCIPAL DISPLAY PANEL - 1.5 L Bottle Label
COLGATE TOTAL 12HR PRO-SHIELD PEPPERMINT BLAST 
cetylpyridinium chloride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 35000-732
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)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Product Characteristics
ColorBLUEScore    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 35000-732-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product
2NDC: 35000-732-84250 mL in 1 BOTTLE; Type 0: Not a Combination Product
3NDC: 35000-732-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product
4NDC: 35000-732-331000 mL in 1 BOTTLE; Type 0: Not a Combination Product
5NDC: 35000-732-501500 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 FINALpart35610/01/2015
Labeler - Colgate-Palmolive Company (068693167)
Establishment
NameAddressID/FEIBusiness Operations
Kleen Test Products Corporation168165814MANUFACTURE(35000-732)

Revised: 12/2015
Document Id: d78cfec5-3585-44a9-9686-865dc332076a
Set id: 946128c1-103b-4018-8a9f-8099ca4d5a63
Version: 1
Effective Time: 20151218
 
Colgate-Palmolive Company