FDA.reportPublic FDA data

Hallo Iceland Kelp Hand Sanitizer

Manufacturer
Kala Corporation
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:51

Label at a glance#

ProductHallo Sapa Volcanic Ash Hand Sanitizer
Active ingredientALCOHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

Apply on hands, rub until dry.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Ethyl Alcohol 65% Antiseptic

Uses

INDICATIONS & USAGE SECTION

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

Uses

OTC - PURPOSE SECTION

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

Warnings

WARNINGS SECTION

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

When using This Product

OTC - WHEN USING SECTION

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

Stop use and ask a doctor

OTC - STOP USE SECTION

if irritation or rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply on hands, rub until dry.

Other information

OTHER SAFETY INFORMATION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

mossmoss

kelpkelpashash

herbherb

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79655-493-012023-07-28C16284748780-10191ceaa-6f78-198a-e063-dbdaa90aec3eHallo Iceland Hand Sanitizers
79655-494-012023-07-28C16284748780-10191ceaa-6f78-198a-e063-dbdaa90aec3eHallo Iceland Hand Sanitizers
79655-495-012023-07-28C16284748780-10191ceaa-6f78-198a-e063-dbdaa90aec3eHallo Iceland Hand Sanitizers
79655-496-012023-07-28C16284748780-10191ceaa-6f78-198a-e063-dbdaa90aec3eHallo Iceland Hand Sanitizers

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79655-493-01Hallo Sapa Volcanic Ash Hand Sanitizer55 g in 1 BOTTLESPRAY552
79655-494-01Hallo Iceland Angelica Herb Hand Sanitizer55 g in 1 BOTTLESPRAY552
79655-495-01Hallo Iceland Kelp Hand Sanitizer55 g in 1 BOTTLESPRAY552
79655-496-01Hallo Iceland Moss Hand Sanitizer55 g in 1 BOTTLESPRAY552

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79655-493HALLO 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]2Legacy NDC, 1 package rows20220114_b77538ca-06c2-193a-e053-2995a90a5f5e.zip
79655-494HALLO 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]2Legacy NDC, 1 package rows20220114_b77538ca-06c2-193a-e053-2995a90a5f5e.zip
79655-495HALLO 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]2Legacy NDC, 1 package rows20220114_b77538ca-06c2-193a-e053-2995a90a5f5e.zip
79655-496HALLO 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]2Legacy NDC, 1 package rows20220114_b77538ca-06c2-193a-e053-2995a90a5f5e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
79655-49379655-493-01
79655-49479655-494-01
79655-49579655-495-01
79655-49679655-496-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
PPG-20 METHYL GLUCOSE ETHER3WV1T97D3KIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MACTIB
AMINOMETHYLPROPANOLLU49E6626QIACT
ALCOHOL3K9958V90MACTIB
PPG-20 METHYL GLUCOSE ETHER3WV1T97D3KIACT
GLYCERINPDC6A3C0OXIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
WATER059QF0KO0RIACT
PPG-20 METHYL GLUCOSE ETHER3WV1T97D3KIACT
ALCOHOL3K9958V90MACTIB
WATER059QF0KO0RIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
ALCOHOL3K9958V90MACTIB
PPG-20 METHYL GLUCOSE ETHER3WV1T97D3KIACT
WATER059QF0KO0RIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
GLYCERINPDC6A3C0OXIACT
ACRYLATES CROSSPOLYMER-64GXD0Q3OS3IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d578f0b0-5e64-1ef2-e053-2995a90ae7c1b77538ca-06c2-193a-e053-2995a90a5f5e2022-01-13WarningsExact identifier
spl id: d578f0b0-5e64-1ef2-e053-2995a90ae7c1
spl set id: b77538ca-06c2-193a-e053-2995a90a5f5e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.