ANTIBIOTIC- neomycin sulfate ointment 
Total Resources International

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 Sulfate (3.5 mg Neomycin)

Purpose

First Aid Antibiotic

Use

first aid to help prevent infection in minor scrapes, cuts, and burns

Warnings

For external use only

Do not use

  • in eyes
  • over large areas of the body or on puncture wounds, animal bites or serious burns
  • for more than 1 week unless directed by a doctor
  • if you are allergic to any of the ingredients

Stop use and ask a doctor if

  • a rash or allergic reaction develops
  • condition worsens or persists

Keep out of reach of children

If ingested, contact a Poison Control Center right away.

Directions

  • clean affected area
  • apply a small amount 1 to 3 times daily
  • may cover with a sterile bandage

Inactive ingredients

mineral oil, petrolatum

Principal Display Panel - 0.03 oz Pouch Label

BE SMART
GET PREPARED®

ANTIBIOTIC
OINTMENT

0.03 oz [0.90 g]

SINGLE USE

Mfd. for: Total Resources Intl.
Walnut, California 91789
00-OIN-21209 Rev.01 • NDC# 55550-730-21

Principal Display Panel - 0.03 oz Pouch Label
ANTIBIOTIC 
neomycin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55550-730
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
mineral oil (UNII: T5L8T28FGP)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55550-730-210.9 g in 1 POUCH; Type 0: Not a Combination Product10/07/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B10/07/2019
Labeler - Total Resources International (790160535)

Revised: 10/2019
Document Id: 519a0081-af90-4c80-8864-035874ce9d52
Set id: 0725364b-b243-4891-af2f-a6049366d038
Version: 1
Effective Time: 20191007
 
Total Resources International