Label: AQUALABS ANTISEPTIC HAND SANITIZER- ethyl alcohol gel

  • 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 16, 2022

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 72% v/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

    Flammable, keep away from fire / flame. 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

    water, glycerin, carbomer, fragrance, triethanolamine, tocopheryl acetate.

  • Questions?

    + 971 6 557 1415

    You may also report serious side effects to this phone number.

    Sat-Thur 9:00 AM - 6:00 PM

  • SPL UNCLASSIFIED SECTION

    KILLS 99.9% OF GERMS

    With Moisturizers & Vitamin E

    MADE IN U.A.E.

    www.aq-private-label.com

    sales@aquatonale.ae

    sales@aquatonale-fze.com

    AQUATONALE GROUP

    Imitation of Graphics/Pack Design is a punishable offence.

    Manufactured by:

    Aquatonale FZC, P6-38, SAIF Zone, Sharjah.

    United Arab Emirates

  • Packaging

    untitled

  • INGREDIENTS AND APPEARANCE
    AQUALABS ANTISEPTIC HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80953-894
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL72 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80953-894-10295.7 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/26/2020
    Labeler - Aquatonale FZC (851675237)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aquatonale FZC851675237manufacture(80953-894)
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