FIRST AID TRIPLE ANTIBIOTIC AND PAIN RELIEF MAXIMUM STRENGTH- bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrocloride ointment 
LIFElabs, a Division of Atico International USA, 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.

----------

LIFElabs, a Division of Atico International USA, INC.

First Aid Triple Antibiotic and Pain Relief (Maximum Strength)

Active Ingredients

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg

Purposes

Warnings

For external use only

Allergy alert:

Do not use

Ask a doctor before use if you have

Stop use and ask a doctor if

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 and older:

Children under 2 years: ask a doctor

Other information

store at 59o - 86oF (15o - 30oC)

Inactive Ingredients

liquid paraffin, methylparaben, polyoxyl 40 stearate, propylparaben, white petrolatum

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.



Uses

Image of Carton Label

Image of Tube Label

FIRST AID TRIPLE ANTIBIOTIC AND PAIN RELIEF  MAXIMUM STRENGTH
bacitracin zinc, neomycin, polymyxin b sulfate, pramoxine hydrocloride ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51852-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin Zinc500 [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 Sulfate10000 [USP'U]  in 1 g
Pramoxine Hydrochloride (UNII: 88AYB867L5) (Pramoxine - UNII:068X84E056) Pramoxine Hydrochloride10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Mineral Oil (UNII: T5L8T28FGP)  
Methylparaben (UNII: A2I8C7HI9T)  
Polyoxyl 40 Stearate (UNII: 13A4J4NH9I)  
Propylparaben (UNII: Z8IX2SC1OH)  
Petrolatum (UNII: 4T6H12BN9U)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51852-100-011 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B11/01/2010
Labeler - LIFElabs, a Division of Atico International USA, INC. (073876450)

Revised: 8/2010
Document Id: cf361d71-0209-4d1d-af56-c29648c5d3fd
Set id: db368653-fce9-4773-af14-08067409529f
Version: 10
Effective Time: 20100823
 
LIFElabs, a Division of Atico International USA, INC.