CVS HEALTH TRIPLE ANTIBIOTIC WITH PAIN RELIEF- bacitracin zinc, polymyxin b sulfate, neomycin sulfate and pramoxine hcl ointment

CVS Health Triple Antibiotic with Pain Relief by

Drug Labeling and Warnings

CVS Health Triple Antibiotic with Pain Relief 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 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine HCL 10 mg 

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain Relief 

Uses

helps prevent infection in and temporarily relieves pain due to 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 1-800-SHOP CVS

Principal Display Panel – Packet Label

CVS Health  NDC: 69842-161-10

Triple Antibiotic Ointment & Pain Relief Bacitracin Zinc Neomycin Sulfate Polymyxin-B Sulfate Pramoxine HCL 
First Aid Antibiotic/Pain relieving Ointment 

NET WT. 0.03 oz. (0.9g)

Principal Display Panel – Carton Label

CVS Health NDC: 69842-161-10

Triple Antibiotic & Pain Relief Ointment 

Bacitracin Zinc Neomycin Sulfate Polymyxin-B SulfatePramoxine HCL
First Aid Antibiotic /Pain relieving Ointment

24 packets 

NET WT. 0.72 oz. (20.4g)
First Aid Treatment for Minor Cuts, Scrapes and Burns

INGREDIENTS AND APPEARANCE

CVS HEALTH TRIPLE ANTIBIOTIC WITH PAIN RELIEF 
bacitracin zinc, polymyxin b sulfate, neomycin sulfate and pramoxine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69842-161
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I)	Bacitracin	500 [USP'U]  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B	10000 [USP'U]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin	3.5 mg  in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 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: 69842-161-10	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(69842-161)