FIRST AID ONLY ANTIBIOTIC NEOMYCIN SULFATE- antibiotic ointment ointment 
Acme United Corporation

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.

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Antibiotic Ointment

Active Ingredient (Each gram contains)

Neomycin sulfate (equivalent to 3.5 mg Neomycin base)

Purpose

First aid antibiotic

Uses

first aid to help prevent infection in

Warnings

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

Ask a doctor before use if you have

  • puncture wounds, animal bites, or serious burns

Stop use and ask a doctor if

  • The condition persists or gets worse
  • A rash or other allergic reaction develops

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

Petrolatum

Questions or comments?

800-835-2263

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FIRST AID ONLY ANTIBIOTIC  NEOMYCIN SULFATE
antibiotic ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0924-5607(NDC:59898-730)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0924-5607-03144 in 1 CARTON12/18/2017
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:0924-5607-0210 in 1 CARTON12/18/2017
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC:0924-5607-0520 in 1 CARTON12/18/2017
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC:0924-5607-010.9 g in 1 PACKET; Type 0: Not a Combination Product04/04/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/18/2017
Labeler - Acme United Corporation (001180207)
Registrant - Acme United Corporation (001180207)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corporation045924339relabel(0924-5607) , repack(0924-5607)
Establishment
NameAddressID/FEIBusiness Operations
Acme United Corpoation080119599relabel(0924-5607) , repack(0924-5607)

Revised: 4/2019
Document Id: 85bc0e54-2b57-6201-e053-2a91aa0ac1fd
Set id: 60a1dbf8-c3b8-105f-e053-2991aa0aa5c7
Version: 2
Effective Time: 20190404
 
Acme United Corporation