Label: BREATH MELLOW WATER LILY- cetylpyridinium chloride spray

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

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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)