OTC Medication Information: CVS Antiseptic

CVS ANTISEPTIC- cetylpyridinium chloride rinse
CVS Pharmacy, Inc

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.

Active ingredient

Cetylpyridinium chloride 0.07%

Purpose

Antigingivitis, Antiplaque

Use

helps control plaque that leads to gingivitis

warnings

for this product

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 gun line, loose teeth or increased 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 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 6 years + older: rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day
  • do not swallow
  • children two years to under 12 years of age: supervise use
  • when used after brushng, rinse mouth with water first
  • children under 6 years of age: do not use

Other information

  • this rinse is not intended to replace brushing or flossing

Inactive ingredients

water, glycerin, flavor, poloxamer 188, sodium saccharin, propylene glycol, sodium benzoate, benzoic acid, blue 1

*This product is not manufactured or distributed by Procter + Gamble, distributor of Crest Pro-Health Multi-Protection Alcohol Free Rinse — Refreshing Clean Mint

This rinse may cause temporary staining to the sufrace of teeth. This is not harmful and adequate brushing may prevent its occurrence.

Distributed by: CVS Pharmacy, Inc.

Once CVS Drive, Woonsocket, RI 02895

CVS.com 1-800-SHOP CVS

principal display panel

ALCOHOL FREE

CVS Health

Compare to the active ingredient in Crest Pro-Health Rinse*

ANTISEPTIC ORAL RINSE

Sealed with printed neckband for your protection

ANTIGINGIVITIS/ANTIPLAQUES

Kills germsHelps keep teeth feeling cleanFreshens breath No burn of alcohol

3 FL OZ (89 mL)

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CVS ANTISEPTIC
cetylpyridinium chloride rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-299
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 0.7 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
POLOXAMER 188
SACCHARIN SODIUM
PROPYLENE GLYCOL
SODIUM BENZOATE
SUCRALOSE
BENZOIC ACID
FD&C BLUE NO. 1
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:59779-299-86 1000 mL in 1 BOTTLE, PLASTIC None
2 NDC:59779-299-21 89 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part356 05/01/2007
Labeler — CVS Pharmacy, Inc (062312574)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 790752542 manufacture (59779-299)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (59779-299)

Revised: 09/2023 CVS Pharmacy, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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