BACITRACIN ZINC- bacitracin zinc 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), POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)

Available from:

STRATUS PHARMACEUTICALS INC

INN (International Name):

BACITRACIN ZINC

Composition:

BACITRACIN 500 [USP'U] in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

First aid to help prevent infection in - minor cuts - scrapes - burns

Authorization status:

OTC monograph final

Summary of Product characteristics

BACITRACIN ZINC- BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT
STRATUS PHARMACEUTICALS 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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BACITRACIN ZINC
_DRUG FACTS_
_ACTIVE INGREDIENT (IN EACH GRAM)_
_PURPOSE_
Bacitracin zinc 500 units
First aid
antibiotic
Polymyxin B 10,000 units
First aid
antibiotic
US ES
First aid to help prevent infection in
minor cuts
scrapes
burns
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
in the eyes
over large areas of the body
ALLERGY ALERT
do not use if allergic to any of the ingredients
WHEN USING THIS PRODUCT
do not use longer then one week unless directed by doctor
ASK A DOCTOR BEFORE USE IF YOU HAVE
deep or puncture wounds
animal bites
serious burns
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
STOP USE AND ASK A DOCTOR IF
condition persists or gets worse
a rash or other allergic reaction develops
DIRECTIONS
Clean the affected area
Apply a small amount of this product on the area 1 to 3 times
May be covered with a sterile bandage
OTHER INFORMATION
Store at room temperature
Before using any medication, read all label directions.
INACTIVE INGREDIENT
White petrolatum
QUESTIONS OR COMMENTS?
Call toll-free 1-800-442-7882
DISTRIBUTED BY: Stratus Pharmaceuticals Inc., 12379 SW 130th Street,
Miami, Florida 33186
PRINCIPAL DISPLAY PANEL - 0.9 G PACKET BOX
NDC 58980-012-01
STRATUSCARE
DOUBLE ANTIBIOTIC
OINTMENT
(Bacitracin Zinc and
Polymyxin B Sulfate Ointment USP)
_FIRST AID ANTIBIOTIC_
_Distributed by:_
STRATUS
PHARMACEUTICALS INC
1 GROSS
Net Wt. 0.9g (1/32 oz) PACKETTES
BACITRACIN ZINC
bacitracin zinc and polymyxin b sulfate ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:58 9 8 0 -0 12
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BACITRACIN ZINC (UNII: 8 9