TRIPLE ANTIBIOTIC - bacitracin zinc, neomycin sulfate, polymyxin b ointment 
Valu Merchandisers, Co.

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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Drug Facts

Active ingredients

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:

Warnings

For external use only

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.

Do not use

if you are allergic to any of the ingredients

Directions

Other information

Inactive ingredients

Cetyl alcohol, Glycerin, Light mineral oil, Steareth-2, Squalane, Stearic acid, Tocopheryl acetate, White petrolatum

Package label panel

Triple Antibiotic Ointmentimage of carton label

TRIPLE ANTIBIOTIC 
bacitracin zinc, neomycin sulfate, polymyxin b ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-314
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [USP'U]  in 1 g
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [USP'U]  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
STEARETH-2 (UNII: V56DFE46J5)  
SQUALANE (UNII: GW89575KF9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63941-314-011 in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B07/16/2012
Labeler - Valu Merchandisers, Co. (868703513)

Revised: 7/2012
Document Id: 90c12c45-4c04-440f-9b35-729d1fc962b6
Set id: 3758e221-df99-48b5-81e5-e9adaaba592f
Version: 1
Effective Time: 20120716
 
Valu Merchandisers, Co.