GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride cloth

Germisept Antibacterial Hand Sanitizing Wipes by

Drug Labeling and Warnings

Germisept Antibacterial Hand Sanitizing Wipes by is a Otc medication manufactured, distributed, or labeled by Innovent Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drugs Fact

Active ingredient

Benzalkonium Chloride 0.1%

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 thorughly with water.

Do not use 

• if irritation and redness develop.

Stop use and ask a doctor 

• if condition persists for more than 72 hours.

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

• Dispose of wipe in the proper container.
• Do not flush down the toilet.

Inactive ingredients

2-Bromo-2-Nitropropane-1,3-Diol, Alcohol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Fragrance, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Propylene Glycol, Tetrasodium EDTA, Water.

Package Labeling:

INGREDIENTS AND APPEARANCE

GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70335-304
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
BRONOPOL (UNII: 6PU1E16C9W)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70335-304-00	1 in 1 BOX	04/15/2020
1		25 in 1 PACKAGE
1		4 mL in 1 PACKAGE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	04/15/2020

Labeler - Innovent Inc (079973489)

Establishment
Name	Address	ID/FEI	Business Operations
American Hygienics Corporation		545198454	manufacture(70335-304)