FDA.reportPublic FDA data

Poly Interferent Mouthwas

Manufacturer
KOunter Dfense BioSciences, Inc.
Effective date
2021-10-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:44:47

Label at a glance#

ProductPoly Interferent Mouthwas
Active ingredientMETHYL SALICYLATE, THYMOL, EUCALYPTOL, MENTHOL, UNSPECIFIED FORM
Label structure10 sections

Indications and uses

Helps Prevent and Reduce Plaque Gingivitis

Dosage and administration

Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonsfuls) morning and night. Do not swallow

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Eucalyptol 0.092%
Menthol 0.042%
Methyl Salicylate 0.060%
Thymol 0.064%

Purposes

OTC - PURPOSE SECTION

Antiplaque/Antigingivitis

Uses

INDICATIONS & USAGE SECTION

Helps Prevent and Reduce

  • Plaque
  • Gingivitis

Warnings

WARNINGS SECTION

Do not use in children under 12 years of age.

Keep out of reach of children.

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

Keep Out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep Out of Reach of Children

Directions

DOSAGE & ADMINISTRATION SECTION

Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonsfuls) morning and night.

Do not swallow

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol (26.9%), Benzoic Acid, Citric Acid Anhydrous, Iota-Carrageenan, Peppermint Oil, Sodium Benzoate, Sorbitol, Water and Xylitol Crystalline

Other Information

OTHER SAFETY INFORMATION

  • Store at room temperature
  • Cold weather may cloud this product, its antiseptic properties are not affected.
  • Do not Use If Seal Cap Is Broken or Missing

Questions/Drug Facts-Back Label

OTC - QUESTIONS SECTION

Drug FactsDrug Facts

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Poly InterferentPoly Interferent

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashPSN1
1043619eucalyptol 0.92 MG/ML / menthol 0.42 MG/ML / methyl salicylate 0.6 MG/ML / thymol 0.64 MG/ML MouthwashSCD1
1043619eucalyptol 0.092 % / menthol 0.042 % / methyl salicylate 0.06 % / thymol 0.064 % MouthwashSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82005-322-042023-01-30C16284748780-1f386c64a-4265-0266-e053-dadaa90a7c1aPoly-I NextGen Formulation Poly Interferent Mouthwash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82005-322-04Poly Interferent Mouthwas118 mL in 1 BOTTLEMOUTHWASH1181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82005-322POLY INTERFERENT MOUTHWAS (EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL) MOUTHWASH [KOUNTER DFENSE BIOSCIENCES, INC.]1Legacy NDC, 1 package rows20211106_cfb17f74-d08b-0ef7-e053-2995a90a0d19.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82005-32282005-322-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
.IOTA.-CARRAGEENAN3582R1F52WIACT
PEPPERMINT OILAV092KU4JHIACT
SODIUM BENZOATEOJ245FE5EUIACT
METHYL SALICYLATELAV5U5022YACTIB
THYMOL3J50XA376EACTIB
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
EUCALYPTOLRV6J6604TKACTIB
BENZOIC ACID8SKN0B0MIMIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SORBITOL506T60A25RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ALCOHOL3K9958V90MIACT

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
cfb17f74-d08c-0ef7-e053-2995a90a0d19cfb17f74-d08b-0ef7-e053-2995a90a0d192021-10-31WarningsExact identifier
spl id: cfb17f74-d08c-0ef7-e053-2995a90a0d19
spl set id: cfb17f74-d08b-0ef7-e053-2995a90a0d19

Reported adverse events (FAERS/openFDA)#

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