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:

H.J. Harkins Company, Inc.

INN (International Name):

Bacitracin Zinc

Composition:

Bacitracin Zinc 500 [USP'U] in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibiotic Antibiotic Uses first aid to help prevent infection in - minor cuts - scrapes - burn Do not use - in the eyes - over large areas of the body - if you are allergic to any of the ingredients Ask a doctor before use in case of deep or puncture wounds, animal bites or serious bums When using this product do not use longer than 1 week unless directed by a doctor Stop use and ask a doctor if - the condition persists or gets worse - if 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. Directions - 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 Other information - do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal • store at room temperature - see crimp of tube for Lot No. and Exp. date Inactive ingredient white petrola

Authorization status:

OTC monograph final

Summary of Product characteristics

BACITRACIN ZINC AND POLYMYXIN B SULFATE - BACITRACIN ZINC AND
POLYMYXIN B
SULFATE OINTMENT
H.J. HARKINS COMPANY, 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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FOUGERA
DOUBLE ANTIBIOTIC OINTMENT
(BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT USP)
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH GRAM)
Bacitracin Zinc (equal to 500 bacitracin units)
Polymyxin B Sulfate (equal to 10,000 polymyxin B units)
PURPOS E
Antibiotic
Antibiotic
_USES_ first aid to help prevent infection in
minor cuts
scrapes
burn
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
in the eyes
over large areas of the body
if you are allergic to any of the ingredients
ASK A DOCTOR BEFORE USE in case of deep or puncture wounds, animal
bites or serious bums
WHEN USING THIS PRODUCT do not use longer than 1 week unless directed
by a doctor
STOP USE AND ASK A DOCTOR IF
the condition persists or gets worse
if 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.
_DIRECTIONS_
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
_OTHER INFORMATION_
do not use if seal is punctured or is not visible. To open, reverse
cap to puncture seal • store at
room temperature
see crimp of tube for Lot No. and Exp. date
_INACTIVE INGREDIENT_ white petrolatum
_QUESTIONS OR COMMENTS ?_ call toll free 1-800-645-9833
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 OZ CONTAINER
Fougera
NDC 0168-0021-35
DOUBLE ANTIBIOTIC OINTMENT
(BACITRACIN ZINC AND POLYMYXIN B SULFATE OINTMENT USP)
Repacked by:
H.J. Harkins Company, Inc.
513 Sandydale Drive
Nipomo, CA 93444
BACITRACIN ZINC AND POLYMYXIN B SULFATE
bacitracin zinc and polymyxin b sulfate ointment
PRODUCT INFORMATION
PRODUCT T