DR TEALS TRIPLE ANTIBIOTIC- bactracin, neomycin, polymyxin b ointment 
Advanced Beauty Systems, 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.

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Dr Teals Tiple Antibiotic ointment

Active Ingredients (in each gram) Purpose

Bacitracin 400 units First aid antibiotic

Neomycin 3.5mg First aid antibiotic

Polymyxin B 5,000 units First aid antibiotic

Uses first aid to help prevent infection in minor -cuts -scrapes -burns

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

-you need to use longer than 1 week

-condition persists or gets worse

-rash or other allergic reaction develop

Warnings For external use only

Do not use -if you are allergic to any ingredients -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

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

Inactive Ingredient: White Petrolatum

image of carton artimage of tube art


Dr Teals

Therapeutic Solutions

First aid relief

Triple Antibiotic Ointment

Bacitracin Zinc

Neomycin Sulfate

Polymyxin B Sulfate

Prevents infection in minor cuts, scrapes, and burns

Net Wt 28 g 1oz

DR TEALS  TRIPLE ANTIBIOTIC
bactracin, neomycin, polymyxin b ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51345-106
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 U  in 28 g
NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 28 g
POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 U  in 28 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51345-106-0128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/06/2012
Labeler - Advanced Beauty Systems, Inc. (129986613)
Registrant - Advanced Beauty Systems, Inc. (129986613)
Establishment
NameAddressID/FEIBusiness Operations
Faria Limited dba Sheffield Pharmaceuticals151177797manufacture(51345-106)

Revised: 8/2012
Document Id: 18987b4b-8c63-4d24-b1f7-5de17ea58614
Set id: d042977d-3333-4522-bce8-28e85f92ceb6
Version: 1
Effective Time: 20120810
 
Advanced Beauty Systems, Inc.