Label: DRS. PHARMACY TRIPLE ANTIBIOTIC PLUS- bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointment
- NDC Code(s): 80489-757-01, 80489-757-02
- Packager: OL PHARMA TECH, LLC Drs PHARMACY
- 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 October 2, 2023
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- Active ingredients
- Uses
- Purpose
- Do Not Use
- WARNINGS
- ASK DOCTOR
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE & ADMINISTRATION
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- Inactive Ingredient
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INGREDIENTS AND APPEARANCE
DRS. PHARMACY TRIPLE ANTIBIOTIC PLUS
bacitracin zinc, neomycin sulfate, polymyxin b sulfate, lidocaine ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:80489-757 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 1000 mg NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1000 mg POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 [USP'U] in 1000 mg PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1000 mg Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:80489-757-01 1 in 1 CARTON 09/05/2021 1 14000 mg in 1 TUBE; Type 0: Not a Combination Product 2 NDC:80489-757-02 1 in 1 CARTON 09/05/2021 2 28300 mg in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 09/05/2021 Labeler - OL PHARMA TECH, LLC Drs PHARMACY (021170377) Registrant - OL PHARMA TECH, LLC Drs PHARMACY (021170377) Establishment Name Address ID/FEI Business Operations OL PHARMA TECH, LLC Drs PHARMACY 021170377 manufacture(80489-757)