Germisept Antibacterial Hand Sanitizing Wipes

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]

GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride cloth 
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

Drug 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 thoroughly 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:

GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70335-001
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 g

Inactive Ingredients
Ingredient Name	Strength
BRONOPOL (UNII: 6PU1E16C9W)
ALCOHOL (UNII: 3K9958V90M)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
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: 70335-001-50	50 in 1 PACKAGE	08/15/2020	08/15/2020
1		4.3 g in 1 PATCH; 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	08/15/2020	08/15/2020

Labeler - INNOVENT INC (079973489)

Revised: 8/2020

Document Id: ae2c6ad8-7f4d-6f71-e053-2a95a90ad70e

34390-5

Set id: fe34c000-499d-4771-8f5b-4447331bac51

Version: 3

Effective Time: 20200831

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