TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Triple Antibiotic Plus Pain Relief by

Drug Labeling and Warnings

Triple Antibiotic Plus Pain Relief by is a Otc medication manufactured, distributed, or labeled by Kareway Product, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each gram)

Bacitracin Zinc 500 units
Neomycin 3.5mg
Polymyxin B Sulfate 10,000 units
Pramoxine HCl 10mg

ACTIVE INGREDIENT

Active ingredients (each gram contains)	Purpose
Bacitracin zinc 500 units	First aid antibiotic
Neomycin sulfate 3.5 mg	First aid antibiotic
Polymyxin B sulfate 10,000 units	First aid antibiotic
Pramoxine HCI 10 mg	External analgesic

Uses

First aid to help prevent infection and provide temporary relief of pain or discomfort in minor

• cuts
• scrapes
• burns
  

Warnings

For external use only

Do not use

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

Ask a doctor before use if you have

Ask a doctor before use if you have

• deep or puncture wounds
• animal bites
• serious burns

Stop use and ask a doctor if

• you need to use longer than 1 week
  
• condition persists or gets worse
• condition persists for more than 1 week, or clear up and occur again within a few days
  
• 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

• adults and children 2 years of age and older:
  • 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
• children under 2 years of age: consult a physician

Other information

store at 20°-25°C (68°-77°F)

PRINCIPAL DISPLAY PANEL

Triple Antibiotic Ointment + Pain Relief
Bacitracin Zinc Neomycin Sulfate Polymyxin B Sulfate Pramoxine HCl

First Aid Antibiotic Ointment

Maximum Strength

NET WT 1 oz (28.3 g)

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

External analgesic

Inactive ingredients

white petrolatum

INGREDIENTS AND APPEARANCE

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, and pramoxine hydrochloride ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67510-0670
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin Zinc - UNII:89Y4M234ES)	Bacitracin Zinc	500 [iU]  in 1 g
Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297)	Neomycin Sulfate	3.5 mg  in 1 g
Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K)	Polymyxin B Sulfate	10000 [iU]  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: 67510-0670-3	1 in 1 CARTON
1		9.4 g in 1 TUBE
2	NDC: 67510-0670-1	1 in 1 CARTON
2		28.3 g in 1 TUBE
3	NDC: 67510-0670-5	1 in 1 CARTON
3		14 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333B	09/12/2011

Labeler - Kareway Product, Inc. (121840057)