GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES- benzalkonium chloride liquid

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., American Hygienics Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

GERMISEPT ANTIBACTERIAL HAND SANITIZING WIPES 
benzalkonium chloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70335-301
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMOMILE (UNII: FGL3685T2X)
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: 70335-301-08	8 in 1 PACKAGE	09/06/2016
1		30 g in 1 PATCH; Type 0: Not a Combination Product

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

Labeler - Innovent Inc. (079973489)

Registrant - American Hygienics Corporation (545198454)

Establishment
Name	Address	ID/FEI	Business Operations
American Hygienics Corporation		545198454	manufacture(70335-301)