Label: HALLO SAPA VOLCANIC ASH HAND SANITIZER- ethyl alcohol solution spray
HALLO ICELAND MOSS HAND SANITIZER- ethyl alcohol solution spray
HALLO ICELAND ANGELICA HERB HAND SANITIZER- ethyl alcohol solution spray
HALLO ICELAND KELP HAND SANITIZER- ethyl alcohol solution spray

  • 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 January 13, 2022

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

  • Active Ingredients

    Ethyl Alcohol 65% Antiseptic

  • Uses

    Sanitizer to help reduce bacteria on skin. For use when soap and water not available.

  • Uses

    Sanitizer to help reduce bacteria on skin. For use when soap and water not available.

  • Warnings

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

  • When using This Product

    Keep out of eyes. In case of contact, flush thoroughly with water. Avoid contact with broken skin.

  • Stop use and ask a doctor

    if irritation or rash occurs.

  • Keep out of reach of children.

    If swallowed, get medical help or contact Poison Control center right away.

  • Directions

    Apply on hands, rub until dry.

  • Other information

    Store between 15-30C (58-86F) Avoid freezing and excess heat above 40C (104F)

  • Inactive ingredients

    Deionized Water, Acrylates Copolymer, Glycerin, PPG20 Methyl Glucose Ether, Fragrance Oil, Aminomethyl Propanol.

  • PRINCIPAL DISPLAY PANEL

    moss

    kelpash

    herb

  • INGREDIENTS AND APPEARANCE
    HALLO SAPA VOLCANIC ASH HAND SANITIZER 
    ethyl alcohol solution spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79655-493
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL33 g  in 55 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 0.55 g  in 55 g
    PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K) 0.275 g  in 55 g
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) 0.55 g  in 55 g
    WATER (UNII: 059QF0KO0R) 19.8 g  in 55 g
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.01 g  in 55 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79655-493-0155 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    HALLO ICELAND MOSS HAND SANITIZER 
    ethyl alcohol solution spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79655-496
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL33 g  in 55 g
    Inactive Ingredients
    Ingredient NameStrength
    PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K) 0.275 g  in 55 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.55 g  in 55 g
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) 0.55 g  in 55 g
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.01 g  in 55 g
    WATER (UNII: 059QF0KO0R) 19.8 g  in 55 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79655-496-0155 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    HALLO ICELAND ANGELICA HERB HAND SANITIZER 
    ethyl alcohol solution spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79655-494
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL33 g  in 55 g
    Inactive Ingredients
    Ingredient NameStrength
    PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K) 0.275 g  in 55 g
    WATER (UNII: 059QF0KO0R) 19.8 g  in 55 g
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) 0.55 g  in 55 g
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.01 g  in 55 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.55 g  in 55 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79655-494-0155 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    HALLO ICELAND KELP HAND SANITIZER 
    ethyl alcohol solution spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79655-495
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL33 g  in 55 g
    Inactive Ingredients
    Ingredient NameStrength
    PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K) 0.275 g  in 55 g
    WATER (UNII: 059QF0KO0R) 19.8 g  in 55 g
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.01 g  in 55 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.55 g  in 55 g
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3) 0.55 g  in 55 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79655-495-0155 g in 1 BOTTLE; Type 0: Not a Combination Product12/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/01/2020
    Labeler - Kala Corporation (623014826)
    Registrant - Kala Corporation (623014826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kala Corporation623014826label(79655-493, 79655-494, 79655-495, 79655-496) , manufacture(79655-493, 79655-494, 79655-495, 79655-496) , pack(79655-493, 79655-494, 79655-495, 79655-496)