Drywired Hand Sanitizer by Cytonix, LLC / Elaine Lanza

Drywired Hand Sanitizer by

Drug Labeling and Warnings

Drywired Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Cytonix, LLC, Elaine Lanza. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRYWIRED HAND SANITIZER- benzalkonium chloride solution 
Cytonix, 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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Benzalkonium Chloride 0.13%

Purpose Antiseptic. Hand and Skin Sanitizer.

Uses To reduce bacteria on skin that could cause disease. Recommended for repeat use.

Warnings

For external use only.

Do not use in eyes.

When using this product avoid contact with eyes.

In case of eye contact flush with plenty of water. Stop use and ask docort if irritation and redness develops.

Keep out of reach of children.

If swallowed, get medical atttention or contact a Poison Control Center.

Keep out of reach of children.

Avoid contact with eyes. In case of contact flush with plenty of water.

Stop use and ask doctor if irritation or redness develop.

3-(Trimethoxylsilyl) Propyl Dimethyl Ocatdecyl Ammonium Chloride, Ethyl Alcohol, Glycerin, Water

Apply liberally to hands and gently rub until dry. Reapply after 4 hours.

Contact

Distributed by Drywired, LLC

Los Angelos, CA 90016

(800) 581-4528

www.drywired.com

Made by Cytonix, LLC

Beltsville, MD USA

79291-655-01 Drywired.jpg

DRYWIRED HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79291-655
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
OCTADECYLDIMETHYL(3-TRIHYDROXYSILYLPROPYL)AMMONIUM CHLORIDE (UNII: GLJ50K866T)	0.5 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1.45 g  in 100 mL
ALCOHOL (UNII: 3K9958V90M)	15 g  in 100 mL
WATER (UNII: 059QF0KO0R)	82.92 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79291-655-01	473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	09/28/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	09/28/2020	10/07/2021

Labeler - Cytonix, LLC (831532705)

Registrant - Elaine Lanza (831532705)

Establishment
Name	Address	ID/FEI	Business Operations
Cytonix, LLC		831532705	manufacture(79291-655)

Revised: 10/2021

Document Id: b6ac70b8-c722-5ac9-e053-2a95a90ab681

34390-5

Set id: b05f5879-7c89-6794-e053-2a95a90a8133

Version: 2

Effective Time: 20211007

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