Label: AQUABAIN ANTIBACTERIAL PASSION BERRYS- benzalkonium chloride 0.13% liquid

  • NDC Code(s): 62476-001-16
  • Packager: Industria La Popular, S.A.
  • 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 December 14, 2021

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antiseptic

  • Uses

    to help reduce bacteria that potentially can cause disease.

  • Warnings

    For External Use only.

  • When using this product

    keep out of eyes, ears, and mouth, in case of contact with eyes, rinse eyes thoroughly with water

  • Stop use

    if irritation or rash occurs. These may be signs of a serious condition.

  • Keep out of reach of children.

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

  • Directions

    Wet hands. Apply palmful to hands. Scrub thoroughly. Rinse thoroughly.

  • Other Information

    Store between 15-30C (59-86F)

  • Inactive Ingredients

    Aqua, Sodium Lauryl Ether Sulfate, Sodium Chloride, Cocamide MEA, Glycerin, Fragrance, Citric Acid, Methylchloroisothiazolinone, Methylisothiazolinone, D&C Red 33, FD&C Blue 1.

  • Aquabain Antibacterial Hand Soap Passion Berrys

    label

  • INGREDIENTS AND APPEARANCE
    AQUABAIN ANTIBACTERIAL PASSION BERRYS 
    benzalkonium chloride 0.13% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62476-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.65 g  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    COCAMIDE (UNII: 3YXD33R71G)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62476-001-16500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/01/2020
    Labeler - Industria La Popular, S.A. (846044576)
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