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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297), PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056), BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)

Available from:

Kareway Product, Inc.

INN (International Name):

NEOMYCIN SULFATE

Composition:

NEOMYCIN SULFATE 3.5 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- BACITRACIN ZINC, NEOMYCIN SULFATE,
POLYMYXIN B SULFATE, AND PRAMOXINE HYDROCHLORIDE OINTMENT
KAREWAY PRODUCT, INC.
_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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PURE-AID TRIPLE ANTIBIOTIC PLUS
_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 Oin