Drywired Alcohol Free Hand Sanitizer by Cytonix, LLC / Elaine Lanza

Drywired Alcohol Free Hand Sanitizer by

Drug Labeling and Warnings

Drywired Alcohol Free 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 ALCOHOL FREE 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%

Topical Antiseptic, Hand and Skin Sanitizer

USES: to reduce bacteria on the skin that could cause disease. Recommended for repeat use.

For external use only.

Do not use in eyes.

When using this product avoid contact with eyes. In case of eye contact flush with water. Stop use and ask a doctor if irritation or redness develops.

Keep out of reach of children.

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

Keep out of reach of children.

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

Stop use and ask doctor if irritation or redness develop.

3-(trimethoxysilyl) Propyl Dimethyl Octadecyl Ammonium Chloride, Glycerin, Water

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

CONTACT:

Cytonix LLC, Beltsville, MD 20705, USA

301-470-6267

www.cytonix.com

DRYWIRED ALCOHOL FREE HAND SANITIZER 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79291-657
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
WATER (UNII: 059QF0KO0R)	98 g  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79291-657-01	473 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	12/22/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	12/22/2020	10/07/2021

Labeler - Cytonix, LLC (831532705)

Registrant - Elaine Lanza (831532705)

Establishment
Name	Address	ID/FEI	Business Operations
Cytonix, LLC		831532705	manufacture(79291-657)

Revised: 10/2021

Document Id: cdc92a7a-a1d9-45bd-e053-2a95a90a0874

34390-5

Set id: b70e7f5b-a340-e95a-e053-2a95a90accde

Version: 2

Effective Time: 20211007

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