Label: LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF- bacitracin, neomycin, polymyxin b, pramoxine hcl ointment
- NDC Code(s): 70000-0390-1
- Packager: Cardinal Health 110, LLC. dba Leader
- 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 June 17, 2021
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each gram)
- Purpose
- Uses
-
Warnings
For external use only.
Do not use
- •
- if you are allergic to any of the ingredients
- •
- in the eyes
- •
- over large areas of the body
- Directions
- Other information
- Inactive ingredient
- Questions or comments?
-
Principal Display Panel
Maximum Strength
Triple Antibiotic Ointment + Pain Relief
Bacitracin Zinc | Neomycin Sulfate | Polymyxin B Sulfate | Pramoxine HCl
COMPARE TO NEOSPORIN® + PAIN RELIEF active ingredients
First Aid Antibiotic Pain Relieving Ointment
Soothes Cuts, Scrapes and Burns
100% Money Back Guarantee
NET WT 1 OZ (28 g)
-
INGREDIENTS AND APPEARANCE
LEADER TRIPLE ANTIBIOTIC AND PAIN RELIEF
bacitracin, neomycin, polymyxin b, pramoxine hcl ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0390 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 500 [USP'U] 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 10000 [USP'U] in 1 g PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Product Characteristics Color YELLOW (Translucent) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0390-1 1 in 1 CARTON 12/13/2018 1 28 g 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 12/13/2018 Labeler - Cardinal Health 110, LLC. dba Leader (063997360)