POLY INTERFERENT MOUTHWAS- eucalyptol, menthol, methyl salicylate, thymol mouthwash
KOunter Dfense BioSciences, Inc.

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.

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Poly-I NextGen Formulation
Poly Interferent Mouthwash

Active Ingredients

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

Purposes

Antiplaque/Antigingivitis

Uses

Helps Prevent and Reduce

Plaque
Gingivitis

Warnings

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

Directions

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

Do not swallow

Inactive Ingredients

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

Other 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

Drug Facts

Principal Display Panel

Poly Interferent

POLY INTERFERENT MOUTHWAS
eucalyptol, menthol, methyl salicylate, thymol mouthwash

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82005-322
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	0.6 mg in 1 mL
THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E)	THYMOL	0.64 mg in 1 mL
EUCALYPTOL (UNII: RV6J6604TK) (EUCALYPTOL - UNII:RV6J6604TK)	EUCALYPTOL	0.92 mg in 1 mL
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	0.42 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
.IOTA.-CARRAGEENAN (UNII: 3582R1F52W)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
WATER (UNII: 059QF0KO0R)
XYLITOL (UNII: VCQ006KQ1E)
BENZOIC ACID (UNII: 8SKN0B0MIM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SORBITOL (UNII: 506T60A25R)
ALCOHOL (UNII: 3K9958V90M)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82005-322-04	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	11/05/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part356	11/05/2021

Labeler - KOunter Dfense BioSciences, Inc. (118118898)

Registrant - KOunter Dfense BioSciences, Inc. (118118898)

Poly-I NextGen Formulation Poly Interferent Mouthwash