FDA.reportPublic FDA data

Hemptuary Hawaii Hand Sanitizer

Manufacturer
Aloha Green Holdings Inc.
Effective date
2022-01-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:46:37

Label at a glance#

ProductHemptuary Hawaii Hand Sanitizer
Active ingredientISOPROPYL ALCOHOL
Label structure12 sections

Dosage and administration

Apply product onto hands, spread thoroughly, cover all surfaces, and rub hands until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 59-86F Avoid freezing and excessive heat above 104F

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.

The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:

  1. Isopropyl Alcohol (75%, v/v) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
  2. Glycerol (1.45% v/v).
  3. Hydrogen peroxide (0.125% v/v).
  4. Sterile distilled water or boiled cold water.

The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Isopropyl Alcohol 75% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

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.

OTC - STOP USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply product onto hands, spread thoroughly, cover all surfaces, and rub hands until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 59-86F
  • Avoid freezing and excessive heat above 104F

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, hydrogen peroxide, purified water USP

Package Label - Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

3785 ml NDC: 73999-002-01

3785 ml label3785 ml label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039900isopropyl alcohol 75 % Topical SolutionPSN2
1039900isopropyl alcohol 0.75 ML/ML Topical SolutionSCD2
1039900isopropyl alcohol 75 % Topical SolutionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73999-002-012024-01-30C16284748780-11030e365-121f-111a-e063-dadaa90a10e2a242449a-4be6-2abd-e053-2995a90a91be

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73999-002-01Hemptuary Hawaii Hand Sanitizer3785 mL in 1 BOTTLELIQUID37852

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73999-002HEMPTUARY HAWAII HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [ALOHA GREEN HOLDINGS INC.]2Legacy NDC, 1 package rows20220113_a242449a-4be6-2abd-e053-2995a90a91be.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73999-00273999-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
HYDROGEN PEROXIDEBBX060AN9VIACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302ACTIB

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
d571b665-8164-b451-e053-2995a90a703aa242449a-4be6-2abd-e053-2995a90a91be2022-01-13WarningsExact identifier
spl id: d571b665-8164-b451-e053-2995a90a703a
spl set id: a242449a-4be6-2abd-e053-2995a90a91be

Reported adverse events (FAERS/openFDA)#

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