FDA Label for 80% Alcohol Hand Sanitizer
View Indications, Usage & Precautions
80% Alcohol Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Phoenix Products Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
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:
- 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 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
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
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
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)
[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
[email protected] | (978) 314-3127
LB0009 Rev A
8 60949 00049 9
* Please review the disclaimer below.