Label: BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE ointment
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Contains inactivated NDC Code(s)
NDC Code(s): 63777-217-01, 63777-217-02 - Packager: Kinray Inc.
- 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 January 21, 2014
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- ACTIVE INGREDIENT
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Warnings:
For external use only
Dosage and Administration
- clean the affected areas
- apply a small amount of product (an amount equal to the surface area of the tip of the finger) on the area 1 to 3 times daily
- may be covered with a sterile bandage
Stop use and ask a doctor if
- the condition persists or gets worse, or if a rash or other allergic reaction develops.
- Purpose
- Ask a doctor before use:
- Other information
- Inactive ingredients:
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
BACITRACIN ZINC, NEOMYCIN SULFATE AND POLYMYXIN B SULFATE
bacitracin zinc, neomycin sulfate and polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63777-217 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 3.5 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:63777-217-01 28.35 g in 1 TUBE 2 NDC:63777-217-02 14.17 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 04/15/2010 Labeler - Kinray Inc. (012574513) Registrant - Dynarex Corporation (008124539) Establishment Name Address ID/FEI Business Operations Galentic Pharma India Private Limited 918531450 manufacture(63777-217)