Label: MEDPRIDE LEMON GLYCERIN- glycerin 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 August 8, 2018

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients

    Glycerin USP 50%

  • PURPOSE

    Purpose

    Oral Demulcent

  • USE

    • for oral care associated with mouth and postoperative mouth care
    • for dry mouth relief
  • warnings

    • Do not use in the eyes

    Stop Use and ask a doctor if

    • If irritation and redness develops
    • the condition persists more than 72 hours

    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 o-30 o C (59 o-86 o F)
    • avoid excessive heat
  • Inactive Ingredients

    Purified Water, Citric Acid, Lemon Flavoring, Sodium Benzoate

  • PRINCIPAL DISPLAY PANEL

    Pouch LabelingCarton Label

  • INGREDIENTS AND APPEARANCE
    MEDPRIDE LEMON GLYCERIN 
    glycerin swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-6134
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.5 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-6134-375 in 1 BOX; Type 0: Not a Combination Product09/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/01/2018
    Labeler - Shield Line LLC (078518916)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!