Label: TOPCARE TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin, polymyxin b, pramoxine hydrochloride ointment
- NDC Code(s): 36800-780-64
- Packager: Topco Associates LLC
- 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 February 28, 2022
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- Official Label (Printer Friendly)
- Active ingredients (in each gram)
- Purpose
- Uses
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Warnings
For external use only.
Do not use
- •
- if you are allergic to any of the ingredients
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- in the eyes
- •
- over large areas of the body
- Directions
- Other information
- Inactive ingredient
- Questions or comments?
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Package/Label Principal Display Panel
COMPARE TO NEOSPORIN® + PAIN RELIEF
ACTIVE INGREDIENTS
First Aid Antibiotic & Pain Relieving Ointment
Helps Prevent Infection in Minor Cuts, Scrapes & Burns
Maximum Strength
TopCare® health
MAXIMUM STRENGTH
Triple Antibiotic Ointment + Pain Relief
BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE & PRAMOXINE HCl
First Aid Antibiotic / Pain Relieving Ointment
NET WT 1 OZ (28 g)
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INGREDIENTS AND APPEARANCE
TOPCARE TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin, polymyxin b, pramoxine hydrochloride ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-780 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:36800-780-64 1 in 1 CARTON 03/15/2020 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 03/15/2020 Labeler - Topco Associates LLC (006935977)