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 
Kala Corporation

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.

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Hallo Iceland Hand Sanitizers

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.

moss

kelpash

herb

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)

Revised: 1/2022
Document Id: d578f0b0-5e64-1ef2-e053-2995a90ae7c1
Set id: b77538ca-06c2-193a-e053-2995a90a5f5e
Version: 2
Effective Time: 20220113
 
Kala Corporation