Label: DR TEALS TRIPLE ANTIBIOTIC- bactracin, neomycin, polymyxin b ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 51345-106-01 - Packager: Advanced Beauty Systems, Inc.
- Category: HUMAN OTC DRUG LABEL
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.
Drug Label Information
Updated August 10, 2012
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- Official Label (Printer Friendly)
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ACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DR TEALS TRIPLE ANTIBIOTIC
bactracin, neomycin, polymyxin b ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51345-106 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 U in 28 g NEOMYCIN (UNII: I16QD7X297) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 28 g POLYMYXIN B (UNII: J2VZ07J96K) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 U in 28 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51345-106-01 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 08/06/2012 Labeler - Advanced Beauty Systems, Inc. (129986613) Registrant - Advanced Beauty Systems, Inc. (129986613) Establishment Name Address ID/FEI Business Operations Faria Limited dba Sheffield Pharmaceuticals 151177797 manufacture(51345-106)