CARDINAL HEALTH FIRST AID ANTIBIOTIC- neomycin sulfate,polymyxin b sulfate,bacitracin zinc ointment
Cardinal Health

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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Drug Facts

Active ingredients (in each gram)

Bacitracin Zinc (400 units)

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

Polymyxin B Sulfate (5,000 units)

Purpose

First Aid Antibiotic

Uses

First aid to help prevent infection in

Minor cuts
Scrapes
Burns

Warnings

For external use only.

Do not use

in the eyes
over large areas of the body
if you are allergic to the ingredients

Ask a doctor before use

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

When using this product

do not use longer than 1 week unless directed by a doctor

Stop use and ask a doctor if

the condition persists or gets worse. If a rash or other allergenic 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 the finger) on the area 1 to 3 times daily
May be covered with a sterile bandage

Other information

do not use if seal is punctured or damaged
store at room temperature

Inactive ingredients

White Soft Paraffin

Principal Display Panel

NDC: 63517-216-05

Triple Antibiotic Ointment

Neomycin Sulfate, Polymyxin B Sulfate, and Bacitracin Zinc Ointment USP

first aid antibiotic

CardinalHealth

Net Wt 1.0 oz (28.3g)

Label

CARDINAL HEALTH FIRST AID ANTIBIOTIC
neomycin sulfate,polymyxin b sulfate,bacitracin zinc ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63517-216
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	400 U in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN	3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	5000 U in 1 g

Ingredient Name	Strength
Inactive Ingredients
PARAFFIN (UNII: I9O0E3H2ZE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63517-216-01	12 in 1 CASE	08/27/2015
1		144 in 1 BOX
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:63517-216-05	100 in 1 CASE	08/27/2015
2		28.3 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:63517-216-02	100 in 1 CASE	08/27/2015
3		14.2 g in 1 TUBE; 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	08/27/2015

Labeler - Cardinal Health (961027315)

Revised: 1/2022

Document Id: d4bb08c7-7ece-4e62-e053-2a95a90a9cdd

Set id: dc83493b-0381-4ba8-a3f7-cb2dc41e5d87

Version: 3

Effective Time: 20220103

Cardinal Health