Label: NILAQUA ANTISEPTIC HAND SANITIZER FOAM- 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 November 7, 2020

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  • Drug Facts

  • Active ingredient

    Benzalkonium chloride 0.8% w/v

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available
  • Warnings

    For external use only

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop
    • 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

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

    • store between 15-30°C (59-86°F)
    • avoid freezing and excessive heat above 40°C (104°F)
  • Inactive ingredients

    amines, c10-16-alkyldimethyl, n-oxides, didecyl dimethyl ammonium chloride, sodium ethylhexyl sulfate, water

  • Questions? +1-855-578-0021

    You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM

  • SPL UNCLASSIFIED SECTION

    Kind to Hands

    Nilaqua®Antiseptic Hand Sanitizer

    Is an alcohol free, antiseptic hand sanitiser that is kind and gentle to the skin.

    • Fragrance Free
    • Fast Drying Formula
    • Kind & Gentle to Skin
    • Vegan Friendly
    • Alcohol & PHMB Free

    Approved:
    BS EN 1276, 1500, 1650
    13623, 13704, 13727, 14348,
    12791, 14476 2013 +A2:2019

    alcoholfreesanitiser.com.√

    Recycle

    Manufactured by: Waterless
    Hope Mill, Stroud,
    Glos, UK, GL5 2SQ

    Made in the UK

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    NILAQUA ANTISEPTIC HAND SANITIZER FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80349-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.8 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    (C10-C16)ALKYLDIMETHYLAMINE OXIDE (UNII: LF6BKC321J)  
    DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
    SODIUM ETHASULFATE (UNII: 12838560LI)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80349-102-0155 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
    2NDC:80349-102-02100 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/08/2020
    3NDC:80349-102-03200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
    4NDC:80349-102-04500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
    5NDC:80349-102-05800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
    6NDC:80349-102-061000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product01/08/2020
    7NDC:80349-102-075000 mL in 1 CONTAINER; Type 0: Not a Combination Product01/08/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/08/2020
    Labeler - WATERLESS LIMITED (211503494)
    Establishment
    NameAddressID/FEIBusiness Operations
    WATERLESS LIMITED211503494manufacture(80349-102)
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