Label: TRIPLE ANTIBIOTIC OINTMENT- bacitracin zinc, neomycin sulfate, polymyxin b ointment
-
Contains inactivated NDC Code(s)
NDC Code(s): 51141-0070-1, 51141-0070-3, 51141-0070-5 - Packager: NeoPharm Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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 25, 2010
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Directions
- Other information
- Inactive ingredients
- Package label panel
-
INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC OINTMENT
bacitracin zinc, neomycin sulfate, polymyxin b ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51141-0070 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC 400 [USP'U] in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 3.5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE 5000 [USP'U] in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) GLYCERIN (UNII: PDC6A3C0OX) LIGHT MINERAL OIL (UNII: N6K5787QVP) STEARETH-2 (UNII: V56DFE46J5) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51141-0070-1 1 in 1 BOX 1 28 g in 1 TUBE 2 NDC:51141-0070-5 1 in 1 BOX 2 14 g in 1 TUBE 3 NDC:51141-0070-3 1 in 1 BOX 3 9.4 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 09/01/2010 Labeler - NeoPharm Co., Ltd (631101883) Registrant - NeoPharm Co., Ltd (631101883) Establishment Name Address ID/FEI Business Operations NeoPharm Co., Ltd 631101883 manufacture