AEROWIPE- anstiseptic wipe swab
Aero Healthcare

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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Aerowipe Antiseptic Wipe

Active Ingredient

Benzalkonium Chloride, 0.13%

Purpose

First Aid Antiseptic

USE

To prevent infection in minor cuts, scrapes and burns

Warnings:

For external use only

Do not use:

For deep puncture wounds, animal bites, or serious burns
In eyes or over large area of the body

Stop use and ask a doctor if:

Irritation, redness, or symptoms develop
the condition persists or gets worse

Keep out of reach of children.

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

Directions:

Tear pouch and clean the affected area.

Inactive Ingredient

Purified Water

Package Label

AW8001 Package

AEROWIPE
anstiseptic wipe swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55305-118
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55305-118-10	1.5 g in 1 POUCH; Type 0: Not a Combination Product	01/01/2016
2	NDC:55305-118-12	25 in 1 BOX	01/01/2016
2		0.1 g in 1 POUCH; 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	part333A	01/01/2016

Labeler - Aero Healthcare (008186174)