BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE 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)

Available from:

Sion Biotext Medical Ltd

INN (International Name):

BACITRACIN ZINC

Composition:

BACITRACIN ZINC 400 [iU] in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First aid to help prevent infection in: - Minor cuts - scrapes - burns - in case of deep or puncture wounds - animal bites - serious burns - if you are allergic to any of the ingredients - in the eyes - over large areas of the body - longer than 1 week unless directed by a doctor - Stop use and ask a doctor if condition persists or gets worse, or if a rash or other allergic reaction occurs

Authorization status:

OTC monograph final

Summary of Product characteristics

BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE-
BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE OINTMENT
SION BIOTEXT MEDICAL LTD
_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._
----------
TRIPLE ANTIBIOTIC OINTMENT
ACTIVE INGREDIENT (IN EA. GRAM) PURPOSE
Bacitracin Zinc 400 Units First Aid Antibiotic
Neomyxin Sulfate 5mg (Equivalent to 3.5 mg Neomyxin) First Aid
Antibiotic
Polymyxin B Sulfate 5000 Units First Aid Antibiotic
USES:
First aid to help prevent infection in:
Minor cuts
scrapes
burns
ASK A DOCTOR BEFORE USE:
in case of deep or puncture wounds
animal bites
serious burns
OTHER INFORMATION
store at controlled room temperature 15°-30° C (59°-86° F)
avoid excessive heat and humidity
INACTIVE INGREDIENTS:
White petrolatum
KEEP OUT OF REACH OF CHILDREN
KEEP OUT OF REACH OF CHILDREN
IF SWALLOWED GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT
AWAY.
WARNINGS
For external use only
DOSAGE AND ADMINISTRATION
clean the affected areas
apply a small amount of product (an amount equal to the surface area
of the tip of
the finger) on the area 1 to 3 times daily
may be covered with a sterile bandage
DO NOT USE:
if you are allergic to any of the ingredients
in the eyes
over large areas of the body
longer than 1 week unless directed by a doctor
STOP USE AND ASK A DOCTOR IF
Stop use and ask a doctor if condition persists or gets worse, or if a
rash or other
allergic reaction occurs
PRINCIPAL DISPLAY PANEL
Sion Biotext Medical Ltd
Triple Antibiotic Ointment
SBM Triple.jpg
BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B
SULFATE
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:68786-216
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNI