Triple Antibiotic Plus Pain Relief (Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate, And Pramoxine Hydrochloride) Ointment [Kareway Product, Inc.] -

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [KAREWAY PRODUCT, INC.]
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NDC	67510-1670-1, 67510-1670-3, 67510-1670-5
Set ID	5542da3f-595f-0612-e054-00144ff8d46c
Category	HUMAN OTC DRUG LABEL
Packager	Kareway Product, Inc.
Generic Name
Product Class	Aminoglycoside Antibacterial
Product Number
Application Number	PART333B

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Active Ingredients (in each gram)

Bacitracin Zinc 500units

Neomycin 3.5mg

Polymyxin B Sulfate 10,000 units

Pramoxine HCl 10mg

Purpose

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.
Other information

store at 20°-25°C (68°-77°F)
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
Inactive ingredients

white petrolatum
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)

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:67510-1670
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg in 1 g
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg in 1 g
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)	BACITRACIN	500 [iU] in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)	POLYMYXIN B	10000 [iU] in 1 g

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67510-1670-3	1 in 1 CARTON	07/26/2017
1		9.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC:67510-1670-1	1 in 1 CARTON	07/26/2017
2		28.3 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC:67510-1670-5	1 in 1 CARTON	07/26/2017
3		14 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	07/26/2017

Labeler - Kareway Product, Inc. (121840057)

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Medic

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE) OINTMENT [KAREWAY PRODUCT, INC.]

Purpose

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

Keep out of reach of children.

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