Label: DR PURE ANTISEPTIC LIQUID HAND NEUTRAL UNSCENTED- benzalkonium chloride liquid

  • NDC Code(s): 78239-003-16
  • Packager: Industrias Bernal Canton S.A. de C.V.
  • 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 June 17, 2021

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.1%

    Purpose

    Antiseptic

  • Use

    For hand washing to decrease bacteria on the skin

  • Warnings

    For external use only.

    Do not use

    in the eyes.

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

    Keep out of reach of children.

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

  • Directions

    • Wet hands and forearms.
    • Apply palmful to hands and forearms.
    • Scrub thoroughly.
    • Rinse and repeat
  • Inactive ingredients

    Water, Sodium Laureth Sulfate, Sodium Chloride, Cocamidopropyl Betaine, DMDM Hydantoin, Glycerol and Aloe Barbadensis Leaf Juice Extract

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    DR PURE ANTISEPTIC LIQUID HAND NEUTRAL UNSCENTED 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78239-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78239-003-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/09/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/09/2021
    Labeler - Industrias Bernal Canton S.A. de C.V. (812827340)
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