OTC Medication Information: ANTISEPTIC

ANTISEPTIC- cetylpyridinium chloride rinse
Valu Merchandisers.Co

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.

Claims

Best Choice Zesty Mint Mouth Rinse

For better oral hygiene and fresher breath

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 gum 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 6 years to under 12 years of age: supervise use
  • when used after brushing, 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, sucralose, benzoic acid, blue 1

Questions?

Call 1-800-593-0593

Adverse Reactions

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

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

Best Choice 100% Guaranteed

www.bestchoicebrand.com

PROUDLY DISTRIBUTED BY:
VALU MERCHANDISERS, CO.

5000 KANSAS AVE.
KANSAS CITY, KS 66106

299.005/299AK/AL

Adverse reaction

Best Choice 100% Guaranteed

www.bestchoicebrand.com

PROUDLY DISTRIBUTED BY:

VALU MERCHANDISERS, CO.

5000 KANSAS AVE.

KANSAS CITY, KS 66106

299.005/299AK/AL

principal display panel

Best Choice

Sealed With Printed Neckband For Your Protection

COMPARE TO THE ACTIVE

INGREDIENT CREST PRO HEALTH

ZESTY MINT

Mouth Rinse

ANTISEPTIC

ANTIGINGIVITIS/ANTIPLAQUE

Kills Germs That Cause Bad Breath, Plaque

& Gingivitis Gum Disease

1 L (33.8 FL OZ)

image description
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ANTISEPTIC
cetylpyridinium chloride rinse
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-299
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:63941-299-86 1000 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 07/31/2007
Labeler — Valu Merchandisers.Co (868703513)
Registrant — Vi-Jon (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon 790752542 manufacture (63941-299), analysis (63941-299)

Revised: 10/2019 Valu Merchandisers.Co

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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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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