NDC | 0404-0360-09, 0404-0360-28, 0404-0360-47, 0404-0360-48 |
Set ID | beaf1fc2-4376-4578-8579-a53b98dfc65c |
Category | HUMAN OTC DRUG LABEL |
Packager | Henry Schein, Inc. |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333B |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
For external use only. Do not use on eyes. Do not use if you are allergic to any of the ingredients due to the possibility of anaphylactic shock.
Stop use and ask a doctor before use in cases of deep puncture wounds, animal bites, serious burns; if the condition persists or gets worse; if a rash or other allergic reaction developes
If swallowed get medical help or contact a poison control center right away
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SCHEIN TRIPLE ANTIBIOTIC
neomycin sulfate, polymyxin b sulfate, bacitracin zinc ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0404-0360 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [iU] in 1 g BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [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:0404-0360-47 144 in 1 BOX 04/21/2015 1 NDC:0404-0360-09 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0404-0360-48 1 in 1 CARTON 04/21/2015 2 NDC:0404-0360-28 28 g in 1 TUBE; 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 04/21/2015 Labeler - Henry Schein, Inc. (012430880) Registrant - Ultraseal Corporation (085752004) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 085752004 pack(0404-0360) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(0404-0360) Establishment Name Address ID/FEI Business Operations Ultra Seal Corporation 944090448 pack(0404-0360)