Label: TRIPLE ANTIBIOTIC- bacitracin zinc neomycin sulfate polymyxin b sulfate ointment
- NDC Code(s): 63187-039-01, 63187-039-15
- Packager: Proficient Rx LP
- This is a repackaged label.
- Source NDC Code(s): 0472-0179
- 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 April 1, 2021
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- INACTIVE INGREDIENT
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PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 63187-039-01
Triple Antibiotic Ointment
FIRST AID ANTIBIOTIC
(Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate Ointment)
First Aid to Help Prevent Infection in Minor Cuts, Scrapes and Burns
Compare to the active ingredients in Neosporin®*
NET WT 1 OZ (28 g)
*This product is not affiliated with, manufactured by, or produced by the makers of Neosporin®.
- 01791210G1 VC110203
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
Made in India
Relabeled by:
Proficient Rx LP
Thousand Oaks, CA 91320
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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:63187-039(NDC:0472-0179) 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:63187-039-15 14 g in 1 TUBE; Type 0: Not a Combination Product 05/01/2015 2 NDC:63187-039-01 28 g in 1 TUBE; Type 0: Not a Combination Product 04/03/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 01/01/2003 Labeler - Proficient Rx LP (079196022) Establishment Name Address ID/FEI Business Operations Proficient Rx LP 079196022 RELABEL(63187-039)
