80% ALCOHOL HAND SANITIZER- alcohol solution

80% Alcohol Hand Sanitizer by

Drug Labeling and Warnings

80% Alcohol Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Phoenix Products Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

The hand rub 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

Purpose

Antiseptic, Hand Rub

Use

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

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

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

STOP USE

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

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

KMS

* Effective at eliminating 99.9% of many

common harmful germs and bacteria.

** Meets the FDA healthcare personnel

antiseptic hand rub criteria

Made in USA

Empty &

Discard Pump

PLASTIC BOTTLE

how2recycle.info

Distributed by

KMS, Inc.

811 E Waterman St.

Wichita, KS 67208

SDA-NE-1013

0 79902 07899 8

ALCOHOL ANTISEPTIC 80 % TOPICAL SOLUTION

HAND
SANITIZER

KILLS 99.9% OF GERMS*

FORMULATED FOR HEALTHCARE**

GENTLE ENOUGH FOR EVERYDAY USE

NON-STERILE LIQUID SOLUTION

WARNING FOR EXTERNAL USE ONLY

FLAMMABLE. KEEP AWAY FROM HEAT OR FLAMES

64 FL OZ (1.89 L)

Package Label - Principal Display Panel

[Kinnos 8 oz]

kinnos

HAND SANITIZER

8 oz (237mL)

We started this company to
protect healthcare workers,
patients, and friends and
family from infections. At
Kinnos, our goal is to
empower people to protect
themselves and others, and
to provide society with
peace of mind.

Join us at www.kinnos.us

Alcohol Antiseptic
(80%)
Topical solution
Non-sterile

Manufactured by Kinnos Inc.

760 Parkside Avenue, Suite 219

Brooklyn, NY 11226

team@kinnos.us | (978) 314-3127

LB0009 Rev A

8 60949 00049 9

INGREDIENTS AND APPEARANCE

80% ALCOHOL HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73956-301
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)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	18.42 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73956-301-64	1893 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020
2	NDC: 73956-301-28	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

80% ALCOHOL HAND SANITIZER 
alcohol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73956-401
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)	1.45 mL  in 100 mL
HYDROGEN PEROXIDE (UNII: BBX060AN9V)	0.125 mL  in 100 mL
WATER (UNII: 059QF0KO0R)	18.42 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73956-401-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	06/01/2020

Labeler - Phoenix Products Company (101332237)

Establishment
Name	Address	ID/FEI	Business Operations
Phoenix Products Company		101332237	manufacture(73956-301, 73956-401)