TRIPLE ANTIBIOTIC- bacitracin, neomycin, polymyxin b ointment
ADVANCED FIRST AID, 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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Active Ingredients (in each gram)

Bacitracin Zinc 400 units

Neomycin Sulfate 5 mg (equivalent to 3.5 mg. Neomycin)

Polymyxin B Sulfate 5000 units

first aid antibiotic

Uses:

First aid to help prevent infection in: • minor cuts • burns • scrapes

Warnings:

• For external use only

Do not use:

• in the eyes • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock • over large areas of the body • longer than 1 week unless directed by a doctor

Stop use and ask a doctor:

• before use in case of deep puncture wounds, animal bites or serious burns

• if the condition persists or gets worse

• if a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control

Center right away.

Directions:

• Clean the affected area.

• Apply a small amount of this product (an amount equal to the surface area of the tip of a finger)on the area 1 to 3 times daily.

• May be covered with a sterile bandage.

Inactive Ingredients: petrolatum.

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TRIPLE ANTIBIOTIC
bacitracin, neomycin, polymyxin b ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:67060-360
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 [iU] in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:67060-360-39	25 in 1 CARTON	04/08/2015	03/01/2024
1		0.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333B	04/08/2015	03/01/2024

Labeler - ADVANCED FIRST AID, INC. (114477180)

Registrant - ADVANCED FIRST AID, INC. (114477180)

Name	Address	ID/FEI	Business Operations
Establishment
ULTRA SEAL CORPORATION		085752004	pack(67060-360)

Name	Address	ID/FEI	Business Operations
Establishment
ULTRA TAB LABORATORIES, INC.		151051757	manufacture(67060-360)

Revised: 1/2023

Document Id: f1b3bb77-b5c5-8f7d-e053-2a95a90a8c19

Set id: 5c8adcb7-b9b5-437c-bc4d-3a568ef9d4e5

Version: 5

Effective Time: 20230107

ADVANCED FIRST AID, INC.