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TRIPLE ANTIBIOTIC by Proficient Rx LP

Medically reviewed on April 3, 2017

Dosage form: ointment
Ingredients: BACITRACIN ZINC 400[iU] in 1g, NEOMYCIN SULFATE 3.5mg in 1g, POLYMYXIN B SULFATE 5000[iU] in 1g
Labeler: Proficient Rx LP
NDC Code: 63187-039

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.

Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate Ointment

ACTIVE INGREDIENTS

(in each gram)

Bacitracin zinc, USP 400 units

Neomycin sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 5,000 units

PURPOSE

First aid antibiotic

USES

Helps prevent infection in

minor cuts
scrapes
burns

WARNINGS

For external  use only

Allergy alert:

do not use if allergic to any of the ingredients

DO NOT USE
in the eyes
over large areas of the body

ASK A DOCTOR BEFORE USE IF YOU HAVE
deep or puncture wounds
animal bites
serious burns

WHEN USING THIS PRODUCT
do not use longer than 1 week unless directed by a doctor

STOP USE AND ASK A DOCTOR IF
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 right away.

DIRECTIONS
clean affected area
apply a small 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
Store at controlled room temperature 59º - 86ºF (15º - 30ºC).
Protect from freezing.

INACTIVE INGREDIENT

White petrolatum

QUESTIONS?

1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63187-039-01

Triple Antibiotic Ointment

FIRST AID ANTIBIOTIC

(Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate Ointment)

First Aid to Help Prevent Infection in Minor Cuts, Scrapes and Burns

Compare to the active ingredients in Neosporin®*

NET WT 1 OZ (28 g)

*This product is not affiliated with, manufactured by, or produced by the makers of Neosporin®.

 
01791210G1 VC110203

Manufactured by: Actavis Mid Atlantic LLC

1877 Kawai Road, Lincolnton, NC 28092 USA

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

TRIPLE ANTIBIOTIC 
bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-039(NDC:0472-0179)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN400 [iU]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B5000 [iU]  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
Packaging
#Item CodePackage Description
1NDC:63187-039-1514 g in 1 TUBE
2NDC:63187-039-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/01/2003
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-039)

 
Proficient Rx LP

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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