AEROWOUND BLOOD CLOTTING FIRST AID- benzethonium chloride and lidocaine aerosol, spray
Aero Healthcare, LLC.

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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AEROWOUND BLOOD CLOTTING SPRAY

Active Ingredients

Benzethonium Chloride 0.2% w/w
Lidocaine 4% w/w

Purpose

Topical Antiseptic
Topical Anesthetic

Uses

for help in control of superficial bleeding and temporary relief of pain of:

minor cuts and scrapes
minor burns

Warnings

For external use only

Flammable

keep away from flame
contents under pressure
do not puncture or incinerate
do not expose to temperatures above 120°F

Do not use

in or near mucous membranes
on serious burns
on raw surfaces
on deep puncture wounds
for a prolonged period of time
on blistered areas
on a large portion of the body
on animal bites

Stop use and ask doctor if

redness, swelling, or irritation occurs
infection occurs
condition persists or worsens
symptoms persist for more than 7 days

Keep out of reach of children.

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

Directions

shake can well before using
hold 6-8 inches from moist injured area
spray until area is covered
for adult use only
not intended for use on children
scab-like cover will gradually disappear as healing takes place or may be removed with soap and water

Inactive Ingredients

Isobutane, Isopropyl Myristate, Karaya, n-Butane, Propane, Silica, Silicone, Sorbitan Monooleate, Talc, Tragacanth

Principal Display

image description

AEROWOUND BLOOD CLOTTING FIRST AID
benzethonium chloride and lidocaine aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55305-114(NDC:52982-106)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	756.5 mg in 85 g
BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP)	BENZETHONIUM CHLORIDE	76.5 mg in 85 g

Ingredient Name	Strength
Inactive Ingredients
ISOBUTANE (UNII: BXR49TP611)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
KARAYA GUM (UNII: 73W9IQY50Q)
BUTANE (UNII: 6LV4FOR43R)
PROPANE (UNII: T75W9911L6)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
3-(TRIETHOXYSILYL)PROPYLAMINE (UNII: L8S6UBW552)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
TALC (UNII: 7SEV7J4R1U)
TRAGACANTH (UNII: 2944357O2O)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:55305-114-10	85 g in 1 BOTTLE, SPRAY

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	08/20/2014

Labeler - Aero Healthcare, LLC. (008186174)

Registrant - Dixon Investments, Inc. (115315822)

Name	Address	ID/FEI	Business Operations
Establishment
Dixon Investments, Inc.		115315822	manufacture(55305-114)