Label: AKOIA HAND SANITIZER- 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 August 7, 2020

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

  • Drug Facts

  • Active Ingredient[s]

    Denatured Alcohol (Ethanol)

  • Purpose

    Antiseptic

  • Use[s]

    Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

  • Warnings

    For external use only. Flammable. Keep away from heat or flame.

    Do not use

    • in children less than 2 months of age

    • on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes

    thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.

    • 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 INGREDIENT

    Inactive ingredients Aqua, Glycerin, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Parfum (Fragrance),

    Aminomethyl Propanol, Aloe Barbadensis (Aloe Vera) Extract.

  • SPL UNCLASSIFIED SECTION

    INFINITE GLOW •

    HAND SANITIZING & Moisturizing Gel

    MOISTURIZING FORMULA

    AKOIA: A hand sanitizing and moisturizing gel that sanitizes your hands while keeping them soft

    and smooth. The formula contains 70% alcohol that helps guarantees maximum possible protection

    against bacteria and germs.

    Produced by:

    NG Beauty World FZCO Dubai, UAE

    For: AXA Beauty World S.R.L.

    Piazza Borromeo, 12 - 20123 Milano, Italy

    AXA Beauty World Limited

    1164 High Road, Whetstone

    London - UK

    www.axabw.com

    Email: info@axabw.com

    Tel: +4407720670777

    Made in UAE

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    AKOIA HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79919-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79919-001-015 mL in 1 PACKET; Type 0: Not a Combination Product08/05/2020
    2NDC:79919-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product08/05/2020
    3NDC:79919-001-03100 mL in 1 TUBE; Type 0: Not a Combination Product08/05/2020
    4NDC:79919-001-04500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/05/2020
    5NDC:79919-001-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/05/2020
    Labeler - NG BEAUTY WORLD FZCO (557947924)
    Establishment
    NameAddressID/FEIBusiness Operations
    NG BEAUTY WORLD FZCO557947924manufacture(79919-001)