Your browser does not support JavaScript! CETYLPYRIDINIUM CHLORIDE MOUTHWASH [SAGE PRODUCTS INC.]
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CETYLPYRIDINIUM CHLORIDE mouthwash
[Sage Products Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Cetylpyridinium chloride .05%

Antiseptic rinse

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

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.

Directions

  • Use up to 4 times daily or as directed by a dentist or doctor.
  • Adults and children 3 years and over: rinse mouth for approximately one minute with 1/2 Tbsp., or use topically (dip into bottle) with clean Toothette(R) oral swab.  Instruct to expectorate.
  • Children under 12 years of age: supervise use.
  • Children under 3 years of age: consult a dentist or doctor.

water, sorbitol, peppermint flavor, potassium sorbate, polysorbate 80, polysorbate 20, citric acid, FD and C Blue 1

label of bottle R4279E

burst pouch label R5267B

CETYLPYRIDINIUM CHLORIDE 
cetylpyridinium chloride mouthwash
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53462-175
Route of AdministrationBUCCALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
cetylpyridinium chloride (cetylpyridinium) cetylpyridinium chloride0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
water 
sorbitol 
peppermint 
potassium sorbate 
polysorbate 80 
polysorbate 20 
citric acid monohydrate 
FD&C Blue No. 1 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53462-175-3044 mL in 1 BOTTLE, PLASTIC
2NDC:53462-175-607 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35612/28/2001
Labeler - Sage Products Inc. (054326178)
Establishment
NameAddressID/FEIBusiness Operations
Sage Products Inc.054326178manufacture

Revised: 3/2012
 
Sage Products Inc.

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