Dosage and administration
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.
Hand Sanitizer
- Manufacturer
- Kuleana Spirits, Inc.
- Effective date
- 2020-12-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- full-release
- Hydrated at
- 2026-05-31 23:36:04
Label at a glance#
ProductHand Sanitizer
Active ingredientALCOHOL
Label structure17 sections
Storage and handling
Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)
Contacts and useful links#
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:
- Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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)
Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
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
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.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive ingredients
glycerin, hydrogen peroxide, purified water USP
80 mL Package Label - Principal Display Panel
[Kuleana Spirits Inc. Logo]
HAND SANITIZER
ANTISEPTIC HAND RUB
(Ethyl Alcohol Formulation for Consumer Use)
ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION
80 ML (2.7 OZ)
Non-sterile Solution
FOR EXTERNAL USE ONLY
NOT SAFE FOR CONSUMPTION
Kuleana Rum Works
61-3270 Maluokalani St, B6
Kawaihae, HI 96743
Made in USA
DATE:______ BATCH:_____ EXP:_____
750 mL Package label. Principal Display Panel
[Kuleana Spirits Inc. Logo]
HAND SANITIZER
ANTISEPTIC HAND RUB
(Ethyl Alcohol Formulation for Consumer Use)
ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION
750 ML
Non-sterile Solution
FOR EXTERNAL USE ONLY
NOT SAFE FOR CONSUMPTION
Kuleana Rum Works
61-3270 Maluokalani St, B6
Kawaihae, HI 96743
Made in USA
DATE:______ BATCH:_____ EXP:_____
NDC 75064-001-01
47 mL Package label. Principal Display Panel
[Kuleana Spirits Inc. Logo]
HAND SANITIZER
ANTISEPTIC HAND RUB
(Ethyl Alcohol Formulation for Consumer Use)
ALCOHOL ANTISEPTIC 80%
TOPICAL SOLUTION
16 OZ
Non-sterile Solution
FOR EXTERNAL USE ONLY
NOT SAFE FOR CONSUMPTION
Kuleana Rum Works
61-3270 Maluokalani St, B6
Kawaihae, HI 96743
Made in USA
DATE:______ BATCH:_____ EXP:_____
19 L Package label. Principal Display Panel
[Kuleana Spirits Inc. Logo]
HAND SANITIZER
Ethanol Antiseptic 80% Topical Solution
HAND SANITIZER FOR REPACKING
Non-sterile Solution
5 Gal | 19 L
Non-potable
Manufactured by:
Kuleana Rum Works
61-3270 Maluokalani St, B6
Kawaihae, HI 96743
888-429-6786
DUNS: 080996182
NDC 75064-001-06
200 L Package label. Principal Display Panel
[Kuleana Spirits Inc. Logo]
HAND SANITIZER
ALCOHOL ANTISEPTIC 80% TOPICAL SOLUTION
Hand Sanitizer for Repackaging
Non-sterile Solution
55 Gal | 200 L
Non-Potable
Manufactured by:
Kuleana Rum Works
61-3270 Maluokalani St, B6
Kawaihae, HI 96743
888-428-6786
DUNS: 090996182 NDC 75064-001-55
DailyMed RxNorm Mappings#
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 5eb9f24b-9328-475e-af0a-18021935eb6a | Product name | 1 | 20180220 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 75064-001-01 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9ae6-a426-e053-dadaa90af4c2 | a334d1bd-b693-73d2-e053-2a95a90a0c35 |
| 75064-001-05 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9ae6-a426-e053-dadaa90af4c2 | a334d1bd-b693-73d2-e053-2a95a90a0c35 |
| 75064-001-16 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9ae6-a426-e053-dadaa90af4c2 | a334d1bd-b693-73d2-e053-2a95a90a0c35 |
| 75064-001-55 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9ae6-a426-e053-dadaa90af4c2 | a334d1bd-b693-73d2-e053-2a95a90a0c35 |
| 75064-001-80 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9ae6-a426-e053-dadaa90af4c2 | a334d1bd-b693-73d2-e053-2a95a90a0c35 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 75064-001-01 | Hand Sanitizer | 750 mL in 1 BOTTLE, GLASS | LIQUID | 750 | 2 | |
| 75064-001-05 | Hand Sanitizer | 19000 mL in 1 JUG | LIQUID | 19000 | 2 | |
| 75064-001-16 | Hand Sanitizer | 47 mL in 1 BOTTLE, PUMP | LIQUID | 47 | 2 | |
| 75064-001-55 | Hand Sanitizer | 200000 mL in 1 DRUM | LIQUID | 200000 | 2 | |
| 75064-001-80 | Hand Sanitizer | 80 mL in 1 BOTTLE, SPRAY | LIQUID | 80 | 2 |
DailyMed Dashboard NDC Coverage#
Products#
Every source-derived product name is available through these pages.
- Hand Sanitizer
- ALCOHOL
- GLYCERIN
- HYDROGEN PEROXIDE
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 75064-001 | 75064-001-01, 75064-001-05, 75064-001-16, 75064-001-80, 75064-001-55 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GLYCERIN | PDC6A3C0OX | IACT |
| HYDROGEN PEROXIDE | BBX060AN9V | IACT |
| WATER | 059QF0KO0R | IACT |
| ALCOHOL | 3K9958V90M | ACTIB |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| b78fb411-7db5-4b8b-e053-2995a90a3761 | a334d1bd-b693-73d2-e053-2a95a90a0c35 | 2020-12-28 | Warnings | b78fb411-7db5-4b8b-e053-2995a90a3761 a334d1bd-b693-73d2-e053-2a95a90a0c35 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.