Label: MEDPRIDE LEMON- glycerin swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 May 6, 2014

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  • Active Ingredient

    Glycerin U.S.P., 7.5% v/v

  • Purpose

    Oral Demulcent

  • Uses

    ■ for oral care associated with mouth and post operative mouth care

    ■ for dry mouth relief

  • Warnings

    ■ Do not use in the eyes

  • Stop use and ask a doctor if

    ■ irritation and redness develops

    ■ the condition persists for more than 72 hours

  • Keep out of reach of children

    In case of accidental overdose, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ swab mouth as needed

    ■ discard after single use

  • Other Information

    ■ store at room temperature:15-30C (59-86F)

    ■ avoid excessive heat

  • Inactive Ingredients

    citric acid u.s.p., lemon flavor, sodium benzoate and water

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MEDPRIDE  LEMON
    glycerin swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-6135
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.075 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (Lemon flavor) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-6135-150 in 1 BOX
    2NDC:52410-6135-375 in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35605/01/2014
    Labeler - Shield Line LLC (078518916)
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