Label: LEMON GLYCERIN- glycerine swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 October 1, 2010

If you are a consumer or patient please visit this version.

  • DOSAGE & ADMINISTRATION

    two swabsticks

    swab freely about the mouth area. patient may suck on swab head to obtain tangy citrus flavor

  • INACTIVE INGREDIENT

    water, citric acid, lime flavor, natrii benzoas

  • INDICATIONS & USAGE

    To refresh dry mouth and throat by providing a tangy citrus flavor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Contains glycerin; overuse may result in a laxative effect.

  • ACTIVE INGREDIENT

    Glycerine

  • WARNINGS

    Contains glycerin; overuse may result in a laxative effect.

  • PURPOSE

    To refresh dry mouth and throat.

  • PRINCIPAL DISPLAY PANEL

    Lemon glycerin swabsticks, triples. For professional and hospital use.
    label
  • INGREDIENTS AND APPEARANCE
    LEMON GLYCERIN 
    glycerine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49953-1894
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.43 mL  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLIME (lime flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49953-1894-11 mL in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/02/2010
    Labeler - Dalian Rongbang Medical Healthy Devices Co (529882730)
    Registrant - Dalian Rongbang Medical Healthy Devices Co (529882730)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dalian Rongbang Medical Healthy Devices Co529882730manufacture