ANTIBIOTIC- neomycin sulfate ointment 
Promex, LLC

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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Drug Facts

Active ingredient (in each gram)

Neomycin 3.5mg

Purposes

First aid antibiotic

Uses

First aid to help prevent infection in minor:

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 one week unless directed by a doctor

Consult a doctor in case of

deep or puncture woundsanimal bitesserious burns

Stop use and ask a doctor if

the condition persists or gets worsea rash or other allergic reaction occurs

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

adults and children 2 years of age and older:

Other information

Inactive ingredients

Cetyl alcohol, Light Mineral Oil, Methylparaben, Propylparaben, Squalane, Tocopheryl acetate, White petrolatum

Package label

Antibiotic Ointment

image of caton label

ANTIBIOTIC 
neomycin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0038
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL (UNII: 936JST6JCN)  
SQUALANE (UNII: GW89575KF9)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PETROLATUM (UNII: 4T6H12BN9U)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58988-0038-11 in 1 BOX
128.35 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B12/05/2013
Labeler - Promex, LLC (789974388)

Revised: 12/2013
Document Id: 3c0ddae5-1273-482b-8fa8-f8b88a99a956
Set id: e1561623-c792-4cb9-bfc1-6d37d1f4bf66
Version: 1
Effective Time: 20131205
 
Promex, LLC