Multi-Action Antiseptic

Manufacturer
Greenbrier International, Inc | Vi-Jon, LLC
Effective date
2023-05-31
Label type
HUMAN OTC DRUG LABEL
Version
11
Source
legacy-cache
Hydrated at
2026-08-01 21:30:34

Label at a glance#

ProductMulti-Action Antiseptic
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure10 sections

Dosage and administration

adults ad 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 brushng, rinse mouth with water first children under 6 years of age: do not use

Label contents#

Full prescribing information#

claims

SPL UNCLASSIFIED SECTION

For better oral hygiene

and fresher breath

active ingredients

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.07%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Use

INDICATIONS & USAGE SECTION

helps control plaque that leads to gingivitis

Warnings

WARNINGS SECTION

for this product

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults ad 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 brushng, rinse mouth with water first
  • children under 6 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • this rinse is not intended to replace brushing or flossing

inactive ingredients

INACTIVE INGREDIENT SECTION

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

disclaimer

SPL UNCLASSIFIED SECTION

*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.

Adverse reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC.

500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO ACTIVE INGREDIENT OF CREST PRO-HEALTH

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

ASSURED

FRESH MINT

ORAL

HEALTH

RINSE

MULTI-ACTION ALCOHOL-FREE ANTISEPTIC

ANTIGINGIVITIS/ANTIPLAQUE

Kills Germs That Cause Bad Breath, Plaque and the Gum Disease Gingivitis

Alcohol Free,

Freshens Breath

16.9 FL OZ (500 mL)

image descriptionimage description

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
33992-029933992-0299-7

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
11e96c0b-2374-ade9-e063-6294a90a7b7f29f9aae0-0dd9-455d-9545-06aa91b73b242024-02-21Warnings, Adverse reactionsExact identifier
spl set id: 29f9aae0-0dd9-455d-9545-06aa91b73b24

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.