HAND ARMOR- benzalkonium chloride liquid
HyGenesis

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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Drug Facts

Active ingredient

Benzalkonium Chloride 0.13%

Purpose

Antimicrobial

Uses

For hand sanitizing to decrease bacteria.

Warnings

For external use only.

When using this product avoid contact with eyes.

In case of contact, flush eyes with water.

Stop use and ask a doctor if

irritation develops or if condition persists for more than 72 hours.

Keep out of reach of children.

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

Directions

Wash hands
Rub in 2 to 4 drops
For Healthcare, repeat process every 4 hours

Inactive ingredients

Cyclopentasiloxane, Dimethicone Crosspolymer, Octadecyldimethyl Trimethoxysilylproply Ammonium Chloride, PPG-3 Benzyl Ether Ethylhexanoate

Questions or commetns?

248-342-8040

image description

HAND ARMOR
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58590-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHYLOCTADECYL(3-(TRIMETHOXYSILYL)PROPYL)AMMONIUM CHLORIDE (UNII: IQ36O85WQ4)
PPG-3 BENZYL ETHER ETHYLHEXANOATE (UNII: 3N703GY99W)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58590-001-01	21.26 g in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2013
2	NDC:58590-001-02	85.05 g in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2013
3	NDC:58590-001-03	170.1 g in 1 BOTTLE; Type 0: Not a Combination Product	09/04/2013

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	09/04/2013

Labeler - HyGenesis (039503442)

Name	Address	ID/FEI	Business Operations
Establishment
Elba, Inc.		108428483	manufacture(58590-001) , label(58590-001) , pack(58590-001)

Drug Facts

﻿Active ingredient

﻿Purpose

﻿Uses

﻿Warnings

﻿When using this product avoid contact with eyes.

﻿Stop use and ask a doctor if

﻿Keep out of reach of children.

﻿Directions

﻿Inactive ingredients

﻿Questions or commetns?