FAMILY CARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin neomycin sulfate polymyxin b sulfate pramoxine hydrochloride ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

United Exchange Corp.

INN (International Name):

POLYMYXIN B SULFATE

Composition:

POLYMYXIN B 10000 [USP'U] in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Uses first aid to help prevent infection and for temporarily relief of pain or discomfort in minor: - cuts - scrapes - burns Do not use - if you are allergic to any of the ingredients - in the eyes - over large areas of the body Stop use and ask a doctor if - you need to use longer than 1 week - symptoms persist for more than 1 week, or clear up and occur again within a few days - the condition persists or gets worse - rash or allerfic reaction develops 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 stearile bandage - children under 2 years of age: ask a doctor

Authorization status:

OTC monograph final

Summary of Product characteristics

FAMILY CARE TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- BACITRACIN NEOMYCIN
SULFATE
POLYMYXIN B SULFATE PRAMOXINE HYDROCHLORIDE OINTMENT
UNITED EXCHANGE CORP.
_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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ACTIVE INGREDIENTS (IN EACH GRAM) PURPOSE
Bacitracin 500
units.......................................................................
First aid antibiotic
Neomycin sulfate 3.5
mg................................................................
First aid antibiotic
Polymyxin B sulfate 10,000
units...................................................... First aid
antibiotic
Pramoxine hydrochloride
10mg........................................................ First aid
antibiotic
US ES
first aid to help prevent infection and for temporarily 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
deep or puncture wounds
animal bites
serious burns
STOP USE AND ASK A DOCTOR IF
you need to use longer than 1 week
symptoms persist for more than 1 week, or clear up and occur again
within a few days
the condition persists or gets worse
rash or allerfic reaction develops
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact Poison Control Center
immediately
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 stearile bandage
children under 2 years of age: ask a doctor
OTHER INFORMATION
store between 20° to 25°C (68° to 77°F)
Lot No. & Exp. Date: see box or see crimp of tube
INACTIVE INGREDIENTS
ethanol, liquid paraffin, methylparaben, polyoxyl 40 stearate,
propylparaben, white petrolatum
DISTRIBUTED BY: