Label: WDC ANTIBACTERIAL TRAVEL WIPES- alcohol and benzalkonium chloride swab

  • NDC Code(s): 78823-016-01
  • Packager: Zhejiang Ruolin Hygienic Products Co., Ltd.
  • 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 July 1, 2020

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  • Active Ingredient

    Ethanol     6%

    Benzalkonium Chloride 0.1%

    Purpose

    Antibacterial

  • USE

    Hand sanitizer to help reduce bacteria on the skin

  • Warning

    • For external use only.
    • Avoid contact with eyes. In case of eye contact, flush eyes with water.
    • Discontinue use if skin irritation occurs. 
    • This prodduct is not intended for use as a baby wipe.

    First Aid:

    For advice, contact a Poison Information Centre or a doctor

    Do nt use for children under 3 years of age.

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

  • Directions

    • For hands, wipe thoroughly for 1 minute and let dry for 2 minutes.
    • To disinfect hard surfaces, wipe and let air dry
    • Do not mix with detergents or other chemicals
    • After use, dispose of wipes in rubbish bin. 
    • Do not flush wipe down the toilet.
  • Inactive ingredients

    Purified Water, Ethanol, Aloe Vera Barbadensis Extract, Phenoxyethanol, Didecyldimethylammonium Chloride, Glycerin, Ethylhexylglycerin, Propylene Glycol

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    WDC ANTIBACTERIAL TRAVEL WIPES 
    alcohol and benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78823-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.10 g  in 100 g
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78823-016-0110 in 1 BAG07/01/2020
    14.05 g in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - Zhejiang Ruolin Hygienic Products Co., Ltd. (415426870)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Ruolin Hygienic Products Co., Ltd.415426870manufacture(78823-016)
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