TRIPLE ANTIBIOTIC- neomycin and polymyxin b sulfates and bacitracin zinc 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:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (International Name):

Bacitracin Zinc

Composition:

Bacitracin Zinc 400 [USP'U] in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibiotic Antibiotic Antibiotic first aid to help prevent infection in - minor cuts - scrapes - burns 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 serous burns 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

Authorization status:

OTC monograph final

Summary of Product characteristics

TRIPLE ANTIBIOTIC- NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN
ZINC OINTMENT
E. FOUGERA & CO. A DIVISION OF FOUGERA 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._
----------
FOUGERA
TRIPLE ANTIBIOTIC OINTMENT
(NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT USP)
DRUG FACTS
ACTIVE INGREDIENTS (IN EACH GRAM)
PURPOS E
Antibiotic
Antibiotic
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
if you are allergic to any of the ingredients
ASK A DOCTOR BEFORE USE in case of deep or puncture wounds, animal
bites or serous burns
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
®
Neomycin Sulfate (5 mg equivalent to 3.5 mg neomycin base)
Polymyxin B Sulfate (equal to 5,000 polymyxin B units)
Bacitracin Zinc (equal to 400 bacitracin units)
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 0168-0012-35
TRIPLE ANTIBIOTIC OINTMENT
(NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC OINTMENT USP)
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 1/2 OZ CARTON
NDC 0168-0012-35