BLACKFORK SPIRITS, LLC HAND SANITIZER- alcohol liquid 
BlackFork Spirits, LLC

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.

US

Active Ingredient(s)

Alcohol 80% v/v. Purpose: Antiseptic

Drug Facts

Purpose

Antiseptic, Hand Sanitizer

Drug

Use

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

use

Warnings

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

warnings

Do not use

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.

when using

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

stop use

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

KOR

Directions

Directs

Other information

OI

Inactive ingredients

glycerin, hydrogen peroxide, purified water USP

IA

Package Label - Principal Display Panel

Clean-Job

HAND SANITIZER

Professional Grade

Non-steril Topical Solution

80% alcohol

18.9271 L NDC: 75093-001-01

473.12 mL NDC: 75093-001-02

946.24 mL NDC: 75093-001-01

FrontFront front

BLACKFORK SPIRITS, LLC HAND SANITIZER 
alcohol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75093-001
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:75093-001-0118927.1 mL in 1 JUG; Type 0: Not a Combination Product03/30/2020
2NDC:75093-001-02473.12 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product03/30/2020
3NDC:75093-001-03946.24 mL in 1 BOTTLE, GLASS; 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 - BlackFork Spirits, LLC (117481909)
Registrant - BlackFork Spirits, LLC (117481909)
Establishment
NameAddressID/FEIBusiness Operations
BlackFork Spirits, LLC117481909manufacture(75093-001)

Revised: 4/2020
Document Id: a3bc1fb1-8b0a-5a7f-e053-2995a90ac114
Set id: a3bc3e8f-4dd7-241a-e053-2995a90a7057
Version: 1
Effective Time: 20200420
 
BlackFork Spirits, LLC