NDC | 53329-087-01, 53329-087-87, 53329-087-96 |
Set ID | 301ebb9a-033b-4f04-99ff-571e921924ca |
Category | HUMAN OTC DRUG LABEL |
Packager | Medline Industries, LP |
Generic Name | |
Product Class | Aminoglycoside Antibacterial |
Product Number | |
Application Number | PART333 |
- Active Ingredient (in each gram)
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Manufacturing Information
- Package Label
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-087 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 [USP'U] in 1 g 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 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-087-01 1 in 1 BOX 01/01/2018 1 28.4 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:53329-087-96 144 in 1 BOX 01/01/2018 2 NDC:53329-087-87 0.9 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:53329-087-87 0.9 g in 1 PACKET; Type 0: Not a Combination Product 01/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/01/2018 Labeler - Medline Industries, LP (025460908)