Label: ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES- benzalkonium chloride cloth

  • 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 September 21, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • ​Active Ingredient

    Benzalkonium Chloride 0.13%

  • ​Purpose

    Antimicrobial

  • Uses

    Hand sanitizer wipes to help reduce bacteria and germs on the skin. Recommended for repeated use.

  • Warnings

    For external use only

    When using this product avoid contacting with eyes. In case of eye contact, rinse eyes with water.

    Stop use and ask a doctor if irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Take wipe and rub thoroughly over all surfaces of both hands. Wet hands thoroughly with wipe and allow to dry, discard after use.
    • Children under 6 years of age should be supervised when using this product.

  • Other information

    Store at room temperature. Keep tightly closed when not in use. Dispose of used wipe in trash. Do not flush.

  • INACTIVE INGREDIENT

    Inactive ingredients Water (Aqua), Phenoxyethanol, Peg 7 glyceryl cocoate, Polysorbate 20, Glycerin, Lime oil, Cocamidopropyl betaine, Citric acid, Limonene, Hexyl Cinnamal, Citral, Citronellol, Geraniol, Benzyl Benzoate, Linalool.

  • SPL UNCLASSIFIED SECTION

    PLUS

    FORMULA

    PROTECTION

    instant effect!

    Free of Paraben, Dye and Phthalates

    SANITIZER

    ANTIBACTERIAL WE WIPES

    FOR HAND SANITIZING TO DECREASE BACTERIA AND GERMS ON THE SKIN

    • Sanitizing formula to help reduce cross-contamination and risk of infection.

    • Leaves no stickiness or residue on hands.

    • Hands feel smooth, soft and refreshed.

    To Open Package:

    • Flip open dispensing lid

    • Locate wipe at center of roll and thread through small opening in lid

    • For best results dispense wipes at an angle

    • Always close lid securely between uses to retain moisture

    TO DISPOSE WIPE: Place in a waste basket after use.

    DO NOT FLUSH

    Distributed by

    Civilon LLC

    Clifton, NJ, 07011

    MADE IN TURKEY

    OZONE FRIENDLY

  • Packaging

    IMAGE

    IMAGE

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ALPS ULTRACLEAN ANTIBACTERIAL WET WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78089-047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LIME OIL (UNII: UZH29XGA8G)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    CITRAL (UNII: T7EU0O9VPP)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    GERANIOL (UNII: L837108USY)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78089-047-0172 in 1 PACKET09/07/2020
    13.67 g in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:78089-047-0272 in 1 CANISTER09/07/2020
    24.11 g in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:78089-047-03100 in 1 CANISTER09/07/2020
    33.24 g in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/05/2020
    Labeler - Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi (565678914)
    Establishment
    NameAddressID/FEIBusiness Operations
    Endeks Kimya Sanayi Ve Ticaret Anonim Sirketi565678914manufacture(78089-047)