Label: KALAYA BREATH REFRESH- mouthwash liquid

  • NDC Code(s): 43493-0005-1
  • Packager: Avaria Health and Beauty Corp
  • Category: HUMAN OTC DRUG LABEL

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 December 21, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • PURPOSE

    Purpose

  • INACTIVE INGREDIENT

    Inactive Ingredients

  • WARNINGS

    Warnings

  • INDICATIONS & USAGE

    Uses

  • DOSAGE & ADMINISTRATION

    Directions

  • PRINCIPAL DISPLAY PANEL

    Kalaya Oral Rinse PDP

  • INGREDIENTS AND APPEARANCE
    KALAYA BREATH REFRESH 
    mouthwash liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43493-0005
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    WATER (UNII: 059QF0KO0R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorPEPPERMINT, SPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43493-0005-1500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product11/16/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/16/2018
    Labeler - Avaria Health and Beauty Corp (251366043)