Label: ASSURED ANTISEPTIC WET WIPES VITAMIN E AND ALOE- 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 April 17, 2019

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  • ASSURED Antiseptic Wet Wipes Vitamin E and Aloe

  • Active Ingredient

    Benzalkonium chloride 0.115%

  • Purpose

    Antiseptic

  • Uses

    For hand washing to decrease bacteria on the skin.

  • Warnings

    For external use only

    Do not use

    • in the eyes
    • if irritation develops
  • When using this product

    • Keep out of eyes, if contact occures, rinse eyes thoroughly with water.
  • Stop use and ask a doctor if

    • irritation develops. Consult a doctor if irritation persists for more than 72hrs.
  • Keep out of the reach of children

     If swallowed, seek medical attention or contact Poison Control Center right away.

  • Directions

    • Wet hands thoroughly with product and allow to dry without wiping.
    • discard wipe in trash receptacle after use.
    • do not flush.
  • Inactive ingredients

    water, aloe vera (aloe barbadensis) leaf extract, propylene, glycol, glycerin, phenoxyethanol, disodium, cocoamphodiacetate, polysorbate 20, sorbitol, disodium EDTA, tocopherol acetate, fragance.

  • ASSURED Antiseptic Wet Wipes Vitamin E and Aloe

    60countlabel

    75countlabel

  • INGREDIENTS AND APPEARANCE
    ASSURED ANTISEPTIC WET WIPES VITAMIN E AND ALOE 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-5111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE (UNII: V5VD430YW9)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITOL (UNII: 506T60A25R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-5111-275 in 1 CANISTER08/19/2013
    13.2 g in 1 PATCH; Type 0: Not a Combination Product
    2NDC:33992-5111-160 in 1 CANISTER08/19/2013
    23.2 g in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/19/2013
    Labeler - Greenbrier International, Inc. (610322518)
    Registrant - Hangzhou Zhongbo Industrial Co., Ltd (421265530)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hangzhou Zhongbo Industrial Co., Ltd421265530manufacture(33992-5111)
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