AEROSOOTHE- triple antibiotic ointment ointment
Aero Healthcare US 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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AEROSOOTHE TRIPLE ANTIBIOTIC OINTMENT

ACTIVE INGREDIENT

Active Ingredients: In each gram-Neomycin Sulfate-5 mg (equivalent to 3.5 mg Neomycin), Polymixin B Sulfate-5000 I.U., Bacitracin Zinc-400 I.U.

Purpose

First Aid Antibiotic

Warnings:

For external use only.

Do not use:

in eyes
over large areas of the body or on puncture wounds, animal bites or serious burns
for more than 1 week unless directed by a doctor
if you are allergic to any of the ingredients due to anaphylactic shock

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

IF INGESTED, CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

CLEAN AFFECTED AREA
APPPLY A SMALL AMOUNT 1 TO 3 TIMES DAILY
MAY COVER WITH A STERILE BANDAGE

INACTIVE INGREDIENT

INACTIVE INGREDIENT: WHITE PETROLATUM

Indications & Usage

FIRST AID TO HELP PREVENT INFECTION IN MINOR SCRAPES, CUTS AND BURNS.

AST05USV2

ASTA05US.POU

AEROSOOTHE
triple antibiotic ointment ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55305-123
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 [iU] in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	5 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:55305-123-02	25 in 1 BOX	02/01/2016
1	NDC:55305-123-01	0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:55305-123-03	0.5 g in 1 PACKET; Type 0: Not a Combination Product	10/20/2015

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	10/20/2015

Labeler - Aero Healthcare US LLC (008186174)