CVS HEALTH TRIPLE ANTIBIOTIC- bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

CVS Health Triple Antibiotic by

Drug Labeling and Warnings

CVS Health Triple Antibiotic by is a Otc medication manufactured, distributed, or labeled by CVS Health, Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients (In each gram)

Bacitracin 400

Neomycin 3.5 mg

Polymyxin B 5,000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection in minor:

• cuts
• scrapes
• burns

Warnings

For external use only

Allergy alert:

• do not use if you are allergic to any of the ingredients

Do not use

• in or near the eyes
• on large areas of the body

Consult a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

When using this product

• do not use longer than 1 week

Stop use and consult a doctor if

• condition persists or gets worse
• symptoms last for more than 7 days or clear up and come back within a few days
• a rash or other allergic reaction develops

Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

• clean the affected area
• apply a small amount (equal to surface area of tip of finger) on the area 1 to 3 times daily.
• may be covered with a sterile bandage

Other information

• Store at a controlled room temperature 68º-77ºF (20º-25ºC)

Inactive ingredient

Petrolatum

Distributed by CVS Pharmacy Inc. 1-800-SHOP CVS

Principal Display Panel – Packet Label

CVS Health  NDC: 69842-162-10

Triple Antibiotic Ointment

Bacitracin Zinc Neomycin Sulfate Polymyxin-B Sulfate
First Aid Antibiotic Ointment

NET WT. 0.03 oz. (0.9g)

Principal Display Panel – Carton Label

CVS Health  NDC: 69842-162-10

Triple Antibiotic OintmentBacitracin Zinc Neomycin Sulfate Polymyxin-B Sulfate
First Aid Antibiotic Ointment

NET WT. 0.03 oz. (0.9g)
First Aid Treatment for Minor Cuts, Scrapes and Burns

INGREDIENTS AND APPEARANCE

CVS HEALTH TRIPLE ANTIBIOTIC 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-162
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	400 [USP'U]  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	5000 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg  in 1 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69842-162-10	24 in 1 CARTON	04/28/2017
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	04/28/2017

Labeler - CVS Health (062312574)

Registrant - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	MANUFACTURE(69842-162)