Label: SHIELDPLEX ANTIBACTERIAL HAND WASH- benzalkonium chloride soap

  • 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 February 9, 2022

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  • Active Ingredient

    Benzalkonium chloride 0.13%

  • Purpose

    Antiseptic skin cleanser

  • Uses

    • Antiseptic (skin) cleanser.
    • Medicated (skin) cleanser.
    • Antibacterial (skin) cleanser.
    • Eliminates harmful bacteria/germs.
    • Effective in destroying (harmful) bacteria to provide antiseptic cleansing.
    • For personal hand hygiene to help prevent the spread of bacteria.
  • Warnings

    For external use only. In case of contact with eyes, rinse eyes thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    Lather in hands with water for at least 30 seconds. Rinse well.

  • Inactive ingredients

    Aqua/Eau/Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Glycol Distearate, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Citric Acid, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Matricaria recutita (Chamomile) Extract, Parfum (Fragrance).

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    SHIELDPLEX ANTIBACTERIAL HAND WASH 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75490-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    GLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHAMOMILE (UNII: FGL3685T2X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75490-004-01946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/12/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/12/2020
    Labeler - CLT Logistics Inc. (243174344)
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