Label: MEDPRIDE STERILE- benzalkonium chloride cloth

  • 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 July 8, 2013

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  • Active Ingredient

    Benzalkonium Chloride 0.133%

  • Purpose

    Antiseptic

  • Uses

    For topical antimicrobial use

  • Warnings

    For external use only
    ■ flammable, keep away from fire or flame

  • Do not use

    ■ with electrocautery procedures ■ in the eyes, if contact occurs, flush eyes with water

  • Stop use and ask a doctor if

    ■if irritation and redness develops. if condition persist consult your health practitioner.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away.

  • Directions

    ■wipe the required site vigorously and discard

  • Other information

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

  • Inactive Ingredients

    purified water, camphor

  • Package Label

    image description

  • INGREDIENTS AND APPEARANCE
    MEDPRIDE  STERILE
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52410-4150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.133 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52410-4150-51000 in 1 CASE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/27/2013
    Labeler - Shield Line LLC (078518916)
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