Label: FIRST AID ONLY NEOMYCIN ANTIBIOTIC- neomycin sulfate ointment
- NDC Code(s): 0924-5620-00, 0924-5620-01, 0924-5620-02
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 61010-6700
- 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 May 4, 2023
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- SPL UNCLASSIFIED SECTION
- Active Ingredient (in each gram)
- Purpose
- INDICATIONS & USAGE
- Warnings:
- Directions
- Inactive ingredients:
- Manufactured for:
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FIRST AID ONLY NEOMYCIN ANTIBIOTIC
neomycin sulfate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-5620(NDC:61010-6700) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN 3.5 mg in 1 g Inactive Ingredients Ingredient Name Strength PETROLATUM (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0924-5620-00 0.9 g in 1 POUCH; Type 0: Not a Combination Product 07/16/2021 2 NDC:0924-5620-01 10 in 1 BOX 05/10/2023 2 0.9 g in 1 POUCH; Type 0: Not a Combination Product 3 NDC:0924-5620-02 20 in 1 BOX 05/10/2023 3 0.9 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 07/16/2021 Labeler - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-5620) , repack(0924-5620) Establishment Name Address ID/FEI Business Operations Acme United Corporation 080119599 relabel(0924-5620) , repack(0924-5620)