ANTISEPTIC ORAL RINSE- cetylpyridinium chloride mouthwash 
Sage Products LLC

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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Antiseptic Oral Rinse

Active ingredient

Cetylpyridinium chloride .05%

Purpose

Antiseptic Rinse

Use

Helps reduce chance of infection in minor oral irritation.

Warnings

Stop use and ask a doctor if:

  • Sore mouth symptoms do not improve in 7 days.
  • Swelling, rash or fever develops.
  • Irritation, pain or redness persists or worsens.

Keep out of reach of children. If more than used for antisepsis 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, Blue 1 (CI42090)

Questions?

Call toll free 800-323-2220

Antiseptic Oral Rinse

AOR packet

ANTISEPTIC ORAL RINSE 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53462-175
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:53462-175-607 mL in 1 PACKET; Type 0: Not a Combination Product12/28/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35606/21/2000
Labeler - Sage Products LLC (054326178)

Revised: 2/2022
Document Id: d8a01fea-681a-2a16-e053-2a95a90ad13f
Set id: efff8bae-154d-46bc-8dd4-716800425663
Version: 8
Effective Time: 20220222
 
Sage Products LLC