NDC | 51345-106-01 |
Set ID | d042977d-3333-4522-bce8-28e85f92ceb6 |
Category | HUMAN OTC DRUG LABEL |
Packager | Advanced Beauty Systems, Inc. |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
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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)