Label: FIRST AID ONLY TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointment
- NDC Code(s): 0924-5618-00, 0924-5618-02, 0924-5618-03, 0924-5618-04
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 61040-226
- 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 7, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredients (in each gram)
- Uses
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Warnings
For external use only
Do not use
- In the eyes
- over large areas of the body
- If you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
- on deep lacerations or puncture wounds, animal bites, or serious burns
- Directions
- Other Information
- Inactive Ingredient
- Questions
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRST AID ONLY TRIPLE ANTIBIOTIC
bacitracin zinc, neomycin sulfate, polymyxin b sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-5618(NDC:61040-226) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN 400 U in 1 g NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 5 mg in 1 g POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B 5000 U in 1 g Inactive Ingredients Ingredient Name Strength WHITE PETROLATUM (UNII: B6E5W8RQJ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-5618-04 60 in 1 BOX 02/24/2023 1 0.5 g in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0924-5618-00 0.5 g in 1 POUCH; Type 0: Not a Combination Product 02/24/2023 3 NDC:0924-5618-02 12 in 1 BOX 06/12/2023 3 0.5 g in 1 POUCH; Type 0: Not a Combination Product 4 NDC:0924-5618-03 25 in 1 BOX 06/12/2023 4 0.5 g in 1 POUCH; 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 02/24/2023 Labeler - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-5618) , repack(0924-5618)