Alcohol Antiseptic Hand Sanitizer 80%

Alcohol Antiseptic Hand Sanitizer 80% by

Drug Labeling and Warnings

Alcohol Antiseptic Hand Sanitizer 80% by is a Otc medication manufactured, distributed, or labeled by KBKK LLC dba Nine Band Brewing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ALCOHOL ANTISEPTIC HAND SANITIZER 80%- alcohol solution 
KBKK LLC dba Nine Band Brewing Company

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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Alcohol Antiseptic Hand Sanitizer 80%

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

Use[s]

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

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

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

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

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

Package Label - Principal Display Panel

Nine Band

Brewing Co

Hand Sanitizer

Made in Allen, Texas

Not for Consumption

Alcohol Antiseptic 80%

Topical Solution Hand Sanitizer

Non-Sterile Solution

33.8 Fl Oz (1000 ML)

ALCOHOL ANTISEPTIC HAND SANITIZER 80% 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77026-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	80 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN PEROXIDE (UNII: BBX060AN9V)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77026-001-01	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020	07/20/2020
2	NDC: 77026-001-02	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020	07/20/2020
3	NDC: 77026-001-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020	07/20/2020
4	NDC: 77026-001-04	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/08/2020	07/20/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/08/2020	07/20/2020

Labeler - KBKK LLC dba Nine Band Brewing Company (076913368)

Establishment
Name	Address	ID/FEI	Business Operations
KBKK LLC dba Nine Band Brewing Company		076913368	manufacture(77026-001)

Revised: 7/2020

Document Id: aaa671c2-38a8-896b-e053-2a95a90a0716

34390-5

Set id: aa05bc6c-3590-9748-e053-2995a90a6c2c

Version: 2

Effective Time: 20200717