Label: FIRST AID ONLY ANTIBIOTIC NEOMYCIN SULFATE- antibiotic ointment ointment
- NDC Code(s): 0924-5607-01, 0924-5607-02, 0924-5607-03, 0924-5607-05
- Packager: Acme United Corporation
- This is a repackaged label.
- Source NDC Code(s): 59898-730
- 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 April 4, 2019
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- Official Label (Printer Friendly)
- Active Ingredient (Each gram contains)
For external use only
Do not use
- in the eyes or apply over large areas of the body
- if you are allergic to any of the ingredients
- longer than 1 week unless directed by a doctor
Stop use and ask a doctor if
- The condition persists or gets worse
- A rash or other allergic reaction develops
- Other information
- Inactive ingredients
- Questions or comments?
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INGREDIENTS AND APPEARANCE
FIRST AID ONLY ANTIBIOTIC NEOMYCIN SULFATE
antibiotic ointment ointment
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0924-5607(NDC:59898-730) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE 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:0924-5607-03 144 in 1 CARTON 12/18/2017 1 0.9 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:0924-5607-02 10 in 1 CARTON 12/18/2017 2 0.9 g in 1 PACKET; Type 0: Not a Combination Product 3 NDC:0924-5607-05 20 in 1 CARTON 12/18/2017 3 0.9 g in 1 PACKET; Type 0: Not a Combination Product 4 NDC:0924-5607-01 0.9 g in 1 PACKET; Type 0: Not a Combination Product 04/04/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333B 12/18/2017 Labeler - Acme United Corporation (001180207) Registrant - Acme United Corporation (001180207) Establishment Name Address ID/FEI Business Operations Acme United Corporation 045924339 relabel(0924-5607) , repack(0924-5607) Establishment Name Address ID/FEI Business Operations Acme United Corpoation 080119599 relabel(0924-5607) , repack(0924-5607)