GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride liquid
Innovent 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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GERMISEPT Antibacterial Hand Sanitizing Wipes

Drugs Fact

Active Ingredient

Benzalkhonium Chloride 0.12%

Purpose

Antibacterial

Uses

Decrease bacteria on the skin.

Warnings

For external use only.

When using this product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Discontinue use if

irritation and redness develop. If condition persists for more than 72 hours consult a doctor.

Keep out of reach of children.

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

Directions

• Open resealable label, remove one wipe to use.

• Wipe hands thoroughly with product and allow to dry without wiping.

• Close resealable label after use to retain moisture.

Other information

• Store below 95° F (35° C) to prevent from drying out.

• Dispose of wipe in the proper container.

• Do not flush down the toilet.

Inactive ingredients

Aqua (Purified & De-Ionized Water), Aloe Barbadensis Leaf Extract, Citric Acid, Didecyldimonium Chloride, 2-Bromo-2-Nitropropane-1,3-Diol, Polyaminopropyl Biguanide, Parfum (Fragrance).

Package Labeling:

tube

GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70335-300
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.12 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
BRONOPOL (UNII: 6PU1E16C9W)
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70335-300-08	8 in 1 PACKAGE	12/14/2015	09/06/2016
1		30 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	12/14/2015	09/06/2016

Labeler - Innovent Inc. (079973489)

Revised: 9/2016

Document Id: 3bdd24a8-3b35-00cd-e054-00144ff8d46c

Set id: 26fd4a42-c131-447d-a545-176ee3328fab

Version: 3

Effective Time: 20160906

Innovent Inc.