NDC | 67060-360-09, 67060-360-28, 67060-360-39, 67060-360-47 |
Set ID | 5c8adcb7-b9b5-437c-bc4d-3a568ef9d4e5 |
Category | HUMAN OTC DRUG LABEL |
Packager | ADVANCED FIRST AID, INC. |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings:
• For external use only
Do not use:
• in the eyes • if you are allergic to any of the ingredients, due to the possibility of anaphylactic shock • over large areas of the body • longer than 1 week unless directed by a doctor
Stop use and ask a doctor:
• before use in case of deep puncture wounds, animal bites or serious burns
• if the condition persists or gets worse
• if a rash or other allergic reaction develops
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin, neomycin, polymyxin b ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67060-360 Route of Administration topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [iU] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67060-360-39 25 in 1 CARTON 04/08/2015 10/17/2016 1 0.5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:67060-360-28 28 g in 1 TUBE; Type 0: Not a Combination Product 10/17/2016 3 NDC:67060-360-47 144 in 1 CARTON 10/17/2016 3 NDC:67060-360-09 0.9 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 04/08/2015 Labeler - ADVANCED FIRST AID, INC. (114477180) Registrant - ADVANCED FIRST AID, INC. (114477180) Establishment Name Address ID/FEI Business Operations ULTRA SEAL CORPORATION 085752004 pack(67060-360) Establishment Name Address ID/FEI Business Operations ULTRA TAB LABORATORIES, INC. 151051757 manufacture(67060-360)