Label: LUCKY ANTIBACTERIAL FOAMING HANDWASH- benzalkonium chloride liquid

  • 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 13, 2017

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Uses

    to decrease bacteria on the skin

  • Warnings

    For external use only

    ■ avoid eye contact. In case of eye contact, flush with water. If irritation occurs discontinue use of product

  • Keep out of reach of children

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

  • Directions

    ■ pump into hands, lather vigorously and rinse

  • Inactive ingredients

    water, cocamidopropyl betaine, decyl glucoside, glycerin, fragrance, citric acid, polyquaternium-7, xanthan gum, methylchloroisothiazolinone, methylisothiazolinone, polysorbate-20, tetrasodium EDTA, aloe barbadensis leaf juice, FDC blue no. 1, DC red no. 33

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    LUCKY  ANTIBACTERIAL FOAMING HANDWASH
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20276-143
    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
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    WATER (UNII: 059QF0KO0R)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) (UNII: 0L414VCS5Y)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20276-143-75221 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/01/2017
    Labeler - Delta Brands, Inc (102672008)
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