Label: FLASHWIPES LIME ALOE- 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 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Benzalkonium Chloride 0.1%

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses

    • to decrease bacteria on the skin
    • recommended for repeated use
  • WARNINGS

    Warnings

    For external use only

    When using this product keep away from eyes. In case of eye contact, rinse eyes with water.

    Stop use and ask a doctor if irritation or redness develop or last more than 72 hours.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    rub wipe thoroughly over all sufaces of both hands and allow to dry.

  • STORAGE AND HANDLING

    Other information

    store between 15-30°C (59-86°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    water, glycerin, methylchloroisothiazolinone, methylisothiazonlinone, PEG-40 hydrogenated castor oil, tetrasodium EDTA, fragrance

  • SPL UNCLASSIFIED SECTION

    MADE IN PERU

    FLASH WIPES IS DISTRIBUTED BY AND IS A REGISTERED TRADEMARK OF

    URBAN ATTITUDES HOLDINGS LTD.

    GREAT NECK, NY 11023(516) 206-3672

  • PRINCIPAL DISPLAY PANEL

    ANTISEPTIC HAND SANITIZER
    FLASHWIPES
    LIME ALOE
    GENTLE ON HANDS TOUGH ON DIRT
    KILLS UP TO 99.99% OF GERMS
    BENZALKONIUM CHLORIDE 0.1%
    15 SHEETS WET WIPES
    6.5 IN. x 6 IN. (15.2 CM x 16.5 CM)

    canister Lime Aloe 011

  • INGREDIENTS AND APPEARANCE
    FLASHWIPES  LIME ALOE
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77185-011
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    EDETATE SODIUM (UNII: MP1J8420LU)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77185-011-1515 in 1 CANISTER09/17/2020
    12.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:77185-011-3030 in 1 PACKET09/17/2020
    22.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/17/2020
    Labeler - Urban Attitudes Holdings Ltd (117502692)
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