Your browser does not support JavaScript! TRIPLE ANTIBIOTIC OINTMENT (BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B) OINTMENT [NEOPHARM CO., LTD]
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TRIPLE ANTIBIOTIC OINTMENT (bacitracin zinc, neomycin sulfate, polymyxin b) ointment
[NeoPharm Co., Ltd]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Active ingredient

Bacitracin Zinc 400 units

Neomycin Sulfate 3.5mg

Polymyxin B Sulfate 5,000 units

Purpose

First aid antibiotic

First aid antibiotic

First aid antibiotic

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

Warnings

For external use only
Do not use if you are allergic to any of the ingredients

Ask a doctor before use if you have

  • serious burns
  • deep or puncture wounds
  • animal bites

When using this product

  • do not use in the eyes
  • do not apply over large areas of the body

Stop use and ask a doctor if

  • you need to use more than 1 week
  • condition persists or gets worse
  • symptoms persist for more than 1 week or clear up and occur again within a few days.
  • 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

  • adults and children 2 years of age or older:
    • clean the affected area
    • apply a small amount of this product (an amount equal tot the surface area of the tip of a finer) on the area 1 to 3 times daily
    • may be covered with a sterile bandage
  • children under 2 years of age:  ask a doctor

Other information

  • store at 59° to 77°F

Inactive ingredients

Cetyl alcohol, Glycerin, Light mineral oil, Myristoyl/palmitoyl oxostearamide/ arachamide MEA, Steareth-w, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

Package label panel

Triple Antibiotic Ointmentimage of a carton

TRIPLE ANTIBIOTIC OINTMENT 
bacitracin zinc, neomycin sulfate, polymyxin b ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51141-0070
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (BACITRACIN) BACITRACIN ZINC400 [USP'U]  in 1 g
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE3.5 mg  in 1 g
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B SULFATE5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
GLYCERIN 
LIGHT MINERAL OIL 
STEARETH-2 
SQUALANE 
STEARIC ACID 
.ALPHA.-TOCOPHEROL ACETATE, D- 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51141-0070-11 in 1 BOX
128 g in 1 TUBE
2NDC:51141-0070-51 in 1 BOX
214 g in 1 TUBE
3NDC:51141-0070-31 in 1 BOX
39.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/01/2010
Labeler - NeoPharm Co., Ltd (631101883)
Registrant - NeoPharm Co., Ltd (631101883)
Establishment
NameAddressID/FEIBusiness Operations
NeoPharm Co., Ltd631101883manufacture

Revised: 8/2010
 
NeoPharm Co., Ltd

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