Label: FRESH N UP- benzalkonium chloride solution

  • 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 September 21, 2010

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  • Active Ingredient

    Benzalkonium chloride 0.115%

  • Purpose

    Antibacterial

  • Uses

    For hand washing to decrease bacteria on the skin
  • Warnings

    For external use only

  • When using this product

    avoid the eyes and mucous membranes
    If contact occurs, rinse eyes thoroughly with water
  • Stop use and ask a doctor if

    if irritation develops and persists for more than 72 hours.
  • Keep out of reach of children

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

  • Other Information

    May be used on face, arms and legs.
  • Directions

    • For use apply thoroughly to hands and face as desired. Allow to dry without wiping. Discard wipe in trash receptacle after use. Do not flush.
    • For dispensing tear open package at notch. Dispose of wrapper in trash. Do  not flush
  • Inactive Ingredients

    Acrylates Copolymer, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, FDC Yellow 5, FDC Blue 1, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Sodium Laureth Sulfate, Water
  • Package Label

    Package label
    image of package label



  • INGREDIENTS AND APPEARANCE
    FRESH N UP 
    benzalkonium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57624-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57624-601-150.115 mL in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2010
    Labeler - Rockline Industries, Inc (066886102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hgiene Salud, S.A. de C.V.814608832manufacture
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