BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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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:

Kinray Inc.

INN (International Name):

BACITRACIN ZINC

Composition:

BACITRACIN 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

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
KINRAY 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
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
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
STOP USE AND ASK A DOCTOR IF
the condition persists or gets worse, or if a rash or other allergic
reaction develops.
INDICATIONS AND USAGE
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
KEEP OUT OF REACH OF CHILDREN
if swallowed, get medical help or contact a Poison Control Center
right away
PURPOS E
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:
Hard Paraffin, Liquid Paraffin, White Soft Paraffin
PRINCIPAL DISPLAY PANEL
Triple Antibiotic Ointment:
triple_antibiotic.jpg
BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointment
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 3777-217
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BACITRACIN ZINC (UNII: 8 9 Y4M234ES) (BACITRACIN - UNII:58 H6 RWO52I)
BACITRACIN
                                
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