Label: DRY MOUTH MOISTURIZINGSPRAY spray

  • NDC Code(s): 84025-097-01
  • Packager: Guangzhou Yanxi Biotechnology Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 29, 2024

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  • DOSAGE & ADMINISTRATION

    Spray directly into mouth on the tongue

  • WARNINGS

    Keep out of children

  • INACTIVE INGREDIENT

    Aqua

  • INDICATIONS & USAGE

    dry mouth

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    dry mouth relief and get fresh breath

  • PRINCIPAL DISPLAY PANEL

    84025-097

  • INGREDIENTS AND APPEARANCE
    DRY MOUTH MOISTURIZINGSPRAY 
    dry mouth moisturizingspray spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84025-097
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL3 mg  in 100 mL
    DIGLYCERIN (UNII: 3YC120743U) (DIGLYCERIN - UNII:3YC120743U) DIGLYCERIN5 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84025-097-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product07/29/2024
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01607/29/2024
    Labeler - Guangzhou Yanxi Biotechnology Co., Ltd (632583102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Yanxi Biotechnology Co., Ltd632583102manufacture(84025-097)