GALENTIC TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hcl ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Galentic Pharma (India) Private Limited

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First aid antibiotic (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5 mg, & Polymyxin B Sulfate 10,000 units) External Analgesic (Pramoxine HCl 10mg) First aid to help prevent infection and for temporary relief of pain in minor cuts, scrapes and burns

Authorization status:

OTC monograph final

Summary of Product characteristics

GALENTIC TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- BACITRACIN ZINC, NEOMYCIN
SULFATE,
POLYMYXIN B SULFATE, PRAMOXINE HCL OINTMENT
GALENTIC PHARMA (INDIA) PRIVATE LIMITED
_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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TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
ACTIVE INGREDIENTS (IN EACH GRAM)
Bacitracin Zinc 500 units
Neomycin Sulfate 3.5 mg
Polymyxin B Sulfate 10,000 units
Pramoxine HCl 10mg
First aid antibiotic (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5
mg, & Polymyxin B Sulfate 10,000
units)
External Analgesic (Pramoxine HCl 10mg)
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER
IMMEDIATELY
First aid to help prevent infection and for temporary relief of pain
in minor cuts, scrapes and burns
FOR EXTERNAL USE ONLY
DO NOT USE
In the eyes
If you are allergic to any of the ingredients
Over large areas of the body
ASK A DOCTOR BEFORE USE IF YOU HAVE
Animal bites
Serious Burns
Deep or puncture wounds
STOP USE AND ASK A DOCTOR IF
You need to use longer than 1 week
condition persists or gets worse
rash or other allergic reaction develops
symptoms persist for more than 1 week, or clear up and occur again
within a few days
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
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: ask a doctor
White Petrolatum
GALENTIC TRIPLE ANTIBIOTIC PLUS PAIN RELIEF
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hcl
ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:50 38 2-0 52
Galentic Pharma (India) Private Limited
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)
BACITRACIN
5