Rexall 542.000/542AA

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-10-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-10-20 03:03:27

Label at a glance#

ProductCetylpyridinium Chloride
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure14 sections

Dosage and administration

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

Label contents#

Full prescribing information#

Tamper Evident Statement

SPL UNCLASSIFIED SECTION

Sealed with printed neckband for your protection

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.05%

Purpose

OTC - PURPOSE SECTION

Antigingivitis, Antiplaque

Use

INDICATIONS & USAGE SECTION

helps control plaque bacteria 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 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.

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 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

SPL UNCLASSIFIED SECTION

  • this rinse is not intended to replace brushing or flossing

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, poloxamer 407, flavor, sucralose, benzoic acid, sodium benzoate

Claims

SPL UNCLASSIFIED SECTION

  • Defends against gum disease and gingivitis
  • Helps prevent bleeding gums
  • Made without artificial colors

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Church & Dwight Co., Inc. distributor of TheraBreath ® Dentist Formulated Healthy Gums Oral Rinse Clean Mint.

Adverse Reaction

ADVERSE REACTIONS SECTION

100% Satisfaction Guaranteed!

(888) 309-9030

DISTRIBUTED BY:

OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Since 1903

Rexall™

Compare to Therabreath ® Healthy Gums Oral Rinse Clean Mint*

Clean Gums

Oral Rinse

Antigingivitis/Antiplaque Mouthrinse

Clean Mint

Helps Fight Gingivitis For 12 Hours

  • Fights Against Bad Breath
  • Alcohol Free
  • Dye Free

10 FL OZ (296 mL)

mm01mm01

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75712-54275712-542-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Source Document#

Source XML

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 5 · 89 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Antigingivitis/AntiplaqueCETYLPYRIDINIUM CHLORIDENice-Pak Products, LLCa66d8d21-1ebf-45e6-97bd-dbe17ee671622026-08-21Warnings, Adverse reactionsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
AntisepticCETYLPYRIDINIUM CHLORIDENice-Pak Products, LLC98c0dadd-c8f9-4955-bd0d-70b14dcf00c22026-08-10Warnings, Adverse reactionsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
CorinzCETYLPYRIDINIUM CHLORIDESage Products, LLC685b6023-89c4-417e-af2d-52e831855da12026-06-29WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Antiplaque solutionCETYLPYRIDINIUM CHLORIDESage Products LLC881d4d08-4b45-486a-93af-18c0e00a5b0e2026-06-29WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Antiseptic Oral RinseCETYLPYRIDINIUM CHLORIDESage Products LLCefff8bae-154d-46bc-8dd4-7168004256632026-06-24Name fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Hello Clean Mint with aloe veraCETYLPYRIDINIUM CHLORIDEColgate-Palmolive Companyb2686d32-3bae-a711-432a-a8cdc21fda382026-06-10WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Hello empower mintCETYLPYRIDINIUM CHLORIDEColgate-Palmolive Company8a85ed51-60b9-450c-84a2-ff6827d663fc2026-06-03WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Cepacol AntibacterialCETYLPYRIDINIUM CHLORIDEReckitt Benckiser LLC7c19eba6-3ebd-497f-9066-6152b72eafdd2026-05-13WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
anzoon ANTIBACTERIAL MOUTH WASHCETYLPYRIDINIUM CHLORIDEShandong AZC Biotechnology Co.,Ltd.507c6896-2806-790c-e063-6394a90ac5ce2026-04-27WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Zestymint AntisepticCETYLPYRIDINIUM CHLORIDEPublix Super Markets, Inc.612400fd-2f59-4434-ab69-abf158a4b8af2026-04-14Warnings, Adverse reactionsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Crest Pro-Health Gum DetoxifyWinter MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6db58f-0b09-d155-e063-6394a90ae6582026-04-14WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Crest Pro-Health Gum Restore Smooth MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6e3b36-e565-7d27-e063-6294a90ae5ac2026-04-14WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Crest Pro-Health Nightly Bacteria ShieldCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f6ec1e0-c6b5-226f-e063-6294a90a8f142026-04-14WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
AHLO PRO Healthy GumsCETYLPYRIDINIUM CHLORIDEGervest USA Inc4f5a0ccb-26e5-ebb6-e063-6394a90abbc52026-04-13WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Crest Scope Original Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f1db6f4-acd7-a665-e063-6294a90a826b2026-04-10WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
GuruNanda Healthy GumsCETYLPYRIDINIUM CHLORIDEGURUNANDA, LLC3e90abec-44f4-e378-e063-6294a90a50fb2026-04-09WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
twice. Oral Wellness Gum ShieldCETYLPYRIDINIUM CHLORIDETwice Twice LLC3d48e2f6-99b6-e8bc-e063-6294a90a1afc2026-04-02WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
CloSYS Silver Healthy GumsCETYLPYRIDINIUM CHLORIDERowpar Pharmaceuticals, Inc.11fd3f31-ee0c-43d2-a856-929d1298277c2026-04-01WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Crest Pro-Health Bold Fresh BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company5692c0ce-a914-08c4-e063-6394a90adf152026-04-01WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE
Brush Buddies Oral Rinse Clean MintCETYLPYRIDINIUM CHLORIDEAshtel Studios, Incf68cbc89-c3b2-4cfa-9b6e-346a73ac85442026-03-13WarningsName fallback
generic name: CETYLPYRIDINIUM CHLORIDE

Reported adverse events (FAERS/openFDA)#

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