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Antibiotic by Promex, LLC

Medically reviewed on December 5, 2017

Dosage form: ointment
Ingredients: NEOMYCIN SULFATE 3.5mg in 1g
Labeler: Promex, LLC
NDC Code: 58988-0038

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 Facts

Active ingredient (in each gram)

Neomycin 3.5mg

Purposes

First aid antibiotic

Uses

First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • burns

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:

  • clean the affected area
  • apply a small amount of this product (an amount equal to the surface area of the tip of a finer) on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 years of age:  ask a doctor

Other information
  • store at room temperature

Inactive ingredients

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

Package label

Antibiotic Ointment

ANTIBIOTIC 
neomycin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-0038
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
SQUALANE 
LIGHT MINERAL OIL 
PETROLATUM 
.ALPHA.-TOCOPHEROL ACETATE, D- 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:58988-0038-11 TUBE (TUBE) 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)

 
Promex, LLC

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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