Label: POLY INTERFERENT MOUTHWAS- eucalyptol, menthol, methyl salicylate, thymol mouthwash
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Contains inactivated NDC Code(s)
NDC Code(s): 82005-322-04 - Packager: KOunter Dfense BioSciences, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 31, 2021
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INGREDIENTS AND APPEARANCE
POLY INTERFERENT MOUTHWAS
eucalyptol, menthol, methyl salicylate, thymol mouthwashProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82005-322 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength 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 Inactive Ingredients Ingredient Name Strength .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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82005-322-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/05/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part356 11/05/2021 Labeler - KOunter Dfense BioSciences, Inc. (118118898) Registrant - KOunter Dfense BioSciences, Inc. (118118898)