Label: 80% ALCOHOL HAND SANITIZER- alcohol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 73956-301-28, 73956-301-64, 73956-401-08 - Packager: Phoenix Products Company
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated June 1, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
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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:
- 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)
- Purpose
- Use
- Warnings
- Do not use
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Other information
- Inactive ingredients
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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
SANITIZERKILLS 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)
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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-sterileManufactured by Kinnos Inc.
760 Parkside Avenue, Suite 219
Brooklyn, NY 11226
team@kinnos.us | (978) 314-3127
LB0009 Rev A
8 60949 00049 9
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INGREDIENTS AND APPEARANCE
80% ALCOHOL HAND SANITIZER
alcohol solutionProduct 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 solutionProduct 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)