Label: CURX ANTIMICROBIAL GEL- benzalkonium chloride gel

  • 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 October 28, 2015

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  • Active Ingredients

    Benzalkonium Ch. 0.13% (i/s*)

  • Purpose

    First Aid Antiseptic

  • Uses

    first aid to to help treat, protect and prevent skin infection associated with

    • minor cuts
    • scrapes
    • burns
  • Warnings

    For external use only

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns

    When using this product

    • Do not use in or near the eyes
    • do not use if you have a history of allergy to any of the ingredients.

    Stop use and ask a doctor if

    • condition worsens
    • symptoms persist for more than 7 days, or clear up and occur again within a few days.

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.


  • Directions

    • adults and children 2 years and older: clean the affected area; apply a small amount on the area 1-3 times daily;may be covered with a sterile bandage (let dry first)
    • children under 2 years: ask a doctor
  • Other Information

    Avoid excessive heat

  • Inactive Ingredients

    USP Petrolatum, Water, Polihexanide (PHMB)

  • Questions?

    1-706-844-1025

  • Principal Display Panel

    GLOBAL HEALTH SOLUTIONS, LLC

    CurXTM Antimicrobial Gel

    First Aid Antimicrobial Gel

    Hospital and Professional Use Only

    Non-Antibiotic

    45 g

    CurX is a registered trademark of Global Health Solutions

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  • *Microdroplet Suspension Technology

    *Proprietary microdroplet suspension technology. Percentage reflective of active ingredient bioavailability in solution.

  • INGREDIENTS AND APPEARANCE
    CURX ANTIMICROBIAL GEL 
    benzalkonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69578-466
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    POLIHEXANIDE (UNII: 322U039GMF)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69578-466-4545 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/28/2015
    Labeler - Global Health Solutions, LLC (079695890)
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Health Solutions, LLC079695890manufacture(69578-466)
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