KALAYA BREATH REFRESH (MOUTHWASH) LIQUID [AVARIA HEALTH AND BEAUTY CORP]

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KALAYA BREATH REFRESH (MOUTHWASH) LIQUID [AVARIA HEALTH AND BEAUTY CORP]
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NDC 43493-0005-1
Set ID 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0
Category HUMAN OTC DRUG LABEL
Packager Avaria Health and Beauty Corp
Generic Name
Product Class
Product Number
Application Number PART356
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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 (248926979)
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