Label: BREATH MELLOW WATER LILY- cetylpyridinium chloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated February 23, 2021

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  • ACTIVE INGREDIENT

    CETYLPYRIDINIUM CHLORIDE 0.05%

  • INACTIVE INGREDIENTS

    Water, Ethanol, Glycerin , Flavor , Xylitol , L-Menthol, Polysorbate 80 , PEG-40 Hydrogenated Castor Oil , Poloxamer 407 , Saccharin Sodium Dihydrate , Enzymatically Modified Stevia Glucosyl Stevia , Cetyl Pyridinium Chloride , Eucalyptus oil , Citric acid, Sodium Citrate, Peony root Extract, Syzygium aromaticum extract , Betula Platyphylla Japonica Bark Extract , Peppermint oil , Green tea Extract , Scutellaria Baicalensis Extract , Nasturtium Officinale Extract , Rubus Idaeus (Raspberry) Fruit Extract , Petroselinum Sativum (Parsley) Extract, Gardenia Jasminoides Fruit Extract

  • PURPOSE

    Oral Antiseptic

  • WARNINGS

    ■ Do not use if you are allergic to any of the ingredients


    Stop use and ask a dentist if ■Swelling, rash or fever develops. ■ Irritation, pain or redness persists or worsens.


    Keep out of the reach of children

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    ■ Helps control bad breath
    ■ aids in the removal or debris, dental plaque and control bacteria.

  • Directions

    ■ Spray directly into mouth, onto the tongue and spread thoroughly inside the mouth.
    ■ Children 12 years and under Not for us unless directed by a healthcare professional

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of bottle

  • INGREDIENTS AND APPEARANCE
    BREATH MELLOW WATER LILY 
    cetylpyridinium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72265-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.0085 g  in 17 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Alcohol (UNII: 3K9958V90M)  
    Glycerin (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72265-102-0117 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other02/01/2021
    Labeler - CURESCRIPT (694894509)
    Registrant - CURESCRIPT (694894509)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biostech Co., Ltd.687294330manufacture(72265-102)
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