ANTIPLAQUE SOLUTION- cetylpyridinium chloride mouthwash 
Sage Products LLC

----------

Antiplaque Solution

Active ingredient

ANTIPLAQUE:
Cetylpyridinium chloride .05%

Purpose

Antigingivitis/antiplaque

Uses

Aids in the removal and prevention of plaque that leads to gingivitis.

Warnings

Stop use and ask a dentist if:

  • Gingivitis, bleeding or redness persists for more than 2 weeks.
  • You have painful or swollen gums, pus from the gum line, loose teeth or increasing spacing between the teeth.  These may be signs or symptoms of periodontitis, a serious form of gum disease.

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

Directions

Inactive ingredients

Water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD&C Blue #1

Questions

 Call toll-free 800-323-2220

Antiplaque Solution Packet
ANTIPLAQUE SOLUTION 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-275
Route of AdministrationBUCCAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
PEPPERMINT (UNII: V95R5KMY2B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-275-607 mL in 1 PACKET; Type 0: Not a Combination Product01/09/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/09/2009
Labeler - Sage Products LLC (054326178)

Revised: 4/2024
Document Id: 174295dd-dde5-008e-e063-6294a90a435d
Set id: 881d4d08-4b45-486a-93af-18c0e00a5b0e
Version: 10
Effective Time: 20240429
 
Sage Products LLC