TRIPLE ANTIBIOTIC- bacitracin zinc and neomycin 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:

Melaleuca, Inc.

INN (International Name):

BACITRACIN ZINC

Composition:

BACITRACIN 500 U in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose antibiotic Uses First aid to help prevent the risk of 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 - longer than one week unless directed by a doctor Stop use and ask a doctor if - the condition persists or gets worse - a rash or other allergic reaction develops

Authorization status:

OTC monograph final

Summary of Product characteristics

TRIPLE ANTIBIOTIC- BACITRACIN ZINC AND NEOMYCIN AND POLYMYXIN B
SULFATE OINTMENT
MELALEUCA, 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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TRIPLE ANTIBIOTIC OINTMENT LABEL
ACTIVE INGREDIENTS (each gram contains:)
Bacitracin zinc
Neomycin
Polymyxin B sulfate
PURPOSE
antibiotic
USES
First aid to help prevent the risk of 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
longer than one week unless directed by a doctor
ASK A DOCTOR
BEFORE USE in case of deep or puncture wounds, animal bites, or
serious burns
STOP USE AND ASK A DOCTOR IF
the condition persists or gets worse
a rash or other allergic reaction develops
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
immediately.
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 1-3 times daily
may be covered with a sterile bandage
Inactive ingredients: Melaleuca Oil (T36-C5
), mineral oil, petrolatum
500 units
3.5 mg
10,000 units
(R)
TRIPLE ANTIBIOTIC
bacitracin zinc and neomycin and polymyxin b sulfate ointment
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:54473-291
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I)
BACITRACIN
500 U in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)
NEOMYCIN SULFATE
3.5 mg in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K)
POLYMYXIN B
10000 U in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
TEA TREE OIL (UNII: VIF565UC2G)
MINERAL OIL (UNII: T5L8T28FGP)
Melaleuca, Inc.
PETROLATUM (UNII: 4T6H12BN9U)
PACKAGING
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