Label: TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 63941-314-01 - Packager: Valu Merchandisers, Co.
- Category: HUMAN OTC DRUG LABEL
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 July 16, 2012
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- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
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Warnings
For external use only
Stop use and ask a doctor if
- you need to use more than 1 week
- condition persists or gets worse
- symptoms persist for more than 1 week or clear up and occur again within a few days.
- rash or other allergic reaction develops
- Directions
- Other information
- Inactive ingredients
- Package label panel
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INGREDIENTS AND APPEARANCE
TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-314 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:63941-314-01 1 in 1 BOX 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 07/16/2012 Labeler - Valu Merchandisers, Co. (868703513)