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Triple Antibiotic by Proficient Rx LP

Medically reviewed on February 1, 2018

Dosage form: ointment
Ingredients: BACITRACIN ZINC 400[USP'U] in 1g, NEOMYCIN SULFATE 3.5mg in 1g, POLYMYXIN B SULFATE 5000[USP'U] in 1g
Labeler: Proficient Rx LP
NDC Code: 63187-649

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)
 
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)

Purpose

Antibiotic
Antibiotic
Antibiotic

Uses

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 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

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 63187-649-15

Triple Antibiotic Ointment
(Neomycin and Polymyxin B Sulfates and Bacitracin Zinc Ointment USP)

TRIPLE ANTIBIOTIC 
neomycin and polymyxin b sulfates and bacitracin zinc ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63187-649(NDC:0168-0012)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN400 [USP'U]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
Packaging
#Item CodePackage Description
1NDC:63187-649-151 TUBE in 1 CARTON
114.17 g in 1 TUBE
2NDC:63187-649-301 TUBE in 1 CARTON
228.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B01/06/2010
Labeler - Proficient Rx LP (079196022)
Establishment
NameAddressID/FEIOperations
Proficient Rx LP079502574RELABEL(63187-649)

 
Proficient Rx LP

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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