HYGEA BENZALKONIUM CHLORIDE ANTISEPTIC TOWELETTE- benzalkonium chloride cloth
Professional Disposables International, Inc.

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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Use

For hand washing to decrease bacteria on the skin

Warnings

For external use only.
If swallowed, get medical help or contact a Poison Control Center right away.
Discontinue use if irritation and redness develop. If condition persists for more than 72 hours consult a doctor.
Do not use in the eyes.

Keep out of reach of children.

Directions

Tear open packet.
Unfold and use; discard in trash receptacle after single use.
Wet hands thoroughly with product and allow to dry without wiping.

Other information

Lot number and expiration date can be found on back panel of packet.

Dosage

Wet hands thoroughly with product and allow to dry without wiping.

Inactive ingredients

Purified Water, Potassium Sorbate, Cocamide DEA, Disodium EDTA, Aloe Barbadensis Leaf Juice

Professional Disposables International, Inc.
Orangeburg, NY 10962-1376 - USA - 1-800-999-6423
Made in USA

Principal Display Panel - 100 Count

Hygea
Benzalkonium Chloride
Antiseptic Towelette

1 Towelette [7.0 x 5.0 in (17.7 x 12.7 cm)] 100 Towelettes per Box

Packet Label

Box Label

Active ingredient

Benzalkonium Chloride 0.13% w/w

Purpose

Antiseptic handwash

HYGEA BENZALKONIUM CHLORIDE ANTISEPTIC TOWELETTE
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10819-3740
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzalkonium Chloride (BENZALKONIUM)	Benzalkonium Chloride	0.13 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER
POTASSIUM SORBATE
COCO DIETHANOLAMIDE
EDETATE DISODIUM
ALOE VERA LEAF

Packaging
#	Item Code	Package Description
1	NDC:10819-3740-1	100 in 1 BOX
1		3.0 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/01/2012

Labeler - Professional Disposables International, Inc. (800777117)

Establishment
Name	Address	ID/FEI	Business Operations
Professional Disposables International, Inc.		800777117	manufacture(10819-3740)

Revised: 09/2012

Document Id: 846e5373-01db-45a4-9bd2-19a8f7dc09ee

Set id: 980c9518-db19-418c-b32c-6c7f34225853

Version: 1

Effective Time: 20120904

Professional Disposables International, Inc.