FDA.reportPublic FDA data

Equate Healthy Gums Clean Mint Breath Oral Rinse

Manufacturer
Vasu Healthcare Pvt. Ltd.
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:53:31

Label at a glance#

ProductEquate Healthy Gums Clean Mint Breath Oral Rinse
Active ingredientCETYLPYRIDINIUM CHLORIDE
Label structure7 sections

Indications and uses

Helps reduce Plaque-associated Gingivitis Helps control gum infections

Dosage and administration

Adults and children 12 years and older : Measure 20ml (4 teaspoonful) and vigorously swish around the mouth and between teeth for 1 minute then spit out. Use undiluted, twice daily, in morning & before bedtime. Children 6 years to under 12 years : Under Adult supervision Children under 6 years : Not recommended for use Do not swallow. In case as excess quantity is swallowed accidently, contact Poison Control Cente...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Cetylpyridinium Chloride 0.05%

Purpose

OTC - PURPOSE SECTION

Anti-Gingivitis/Anti-Plaque

Uses

INDICATIONS & USAGE SECTION

  • Helps reduce Plaque-associated Gingivitis
  • Helps control gum infections

Warnings

WARNINGS SECTION

Stop use and ask 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 increasing spacing between teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.

Keep out of reach of children 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

under 6 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years and older : Measure 20ml (4 teaspoonful) and vigorously swish around the mouth and between teeth for 1 minute then spit out. Use undiluted, twice daily, in morning & before bedtime.

Children 6 years to under 12 years : Under Adult supervision

Children under 6 years : Not recommended for use

  • Do not swallow. In case as excess quantity is swallowed accidently, contact Poison Control Center for immediate care and attention.

Other information

SPL UNCLASSIFIED SECTION

Do not exceed the recommended dosage. This rinse is not a substitute for brushing or flossing. Do not use if safety seal is broken or missing.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, PEG-40 Hydrogenated castor oil, Sodium benzoate, Citric acid, Flavour, Sucralose

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.jpgLabel.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1251617cetylpyridinium chloride 0.05 % MouthwashPSN3
1251617cetylpyridinium chloride 0.5 MG/ML MouthwashSCD3
1251617cetylpyridinium chloride 0.05 % MouthwashSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84239-000-00Equate Healthy Gums Clean Mint Breath Oral Rinse475 mL in 1 BOTTLELIQUID4753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84239-000EQUATE HEALTHY GUMS CLEAN MINT BREATH ORAL RINSE (CETYLPYRIDINIUM CHLORIDE) LIQUID [VASU HEALTHCARE PVT. LTD.]3Current NDC, 1 package rows20250125_05fc922a-73fc-4826-be77-538da08282b9.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84239-00084239-000-00

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
SUCRALOSE96K6UQ3ZD4IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PACTIB

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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Healthy Gums Clean Mint Breath Oral RinseCETYLPYRIDINIUM CHLORIDEVasu Healthcare Pvt. Ltd.05fc922a-73fc-4826-be77-538da08282b92024-12-11WarningsExact identifier
ndc (package): 84239-000-00
ndc (product): 84239-000
ndc11 (package): 84239000000
spl id: 2901a1df-7cd4-7cf2-e063-6394a90a8c91
spl set id: 05fc922a-73fc-4826-be77-538da08282b9

Reported adverse events (FAERS/openFDA)#

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