HAND SANITIZER- alcohol liquid 
Kuleana Spirits, Inc.

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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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. 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.
  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)

Alcohol 80% v/v. Purpose: Antiseptic

Back label

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

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.

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.

Directions

Other information

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:_____

80 mL front label

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

750 mL front label

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:_____

16 oz front label

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

5 Gal front label

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

200 L front label

HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75064-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75064-001-01750 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/30/2020
2NDC:75064-001-0519000 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
3NDC:75064-001-1647 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/15/2020
4NDC:75064-001-8080 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/15/2020
5NDC:75064-001-55200000 mL in 1 DRUM; Type 0: Not a Combination Product03/30/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A03/30/2020
Labeler - Kuleana Spirits, Inc. (080996182)
Establishment
NameAddressID/FEIBusiness Operations
Kuleana Spirits, Inc.080996182manufacture(75064-001)

Revised: 12/2020
Document Id: b78fb411-7db5-4b8b-e053-2995a90a3761
Set id: a334d1bd-b693-73d2-e053-2a95a90a0c35
Version: 2
Effective Time: 20201228
 
Kuleana Spirits, Inc.