Label: ROOSIN NEOMYCIN ANTIBIOTIC- neomycin sulfate ointment

  • 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 December 15, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Neomycin Sulfate 0.556%

  • Purpose

    First Aid Antibiotic

  • Use

    First aid to help prevent infection in minor cuts scrapes burns

  • WARNINGS

    For external use only

    Do not use

    • In eyes
    • Over large areas of the body
    • For more than one week unless directed by a doctor
    • If you are allergic to any of the ingredients

    Ask doctor before use if you have puncture wounds, animal bites, or serious burns

    Stop use an ask a doctor if 

    • A rash or allergic reaction develops
    • Condition worsens or persists

    Keep out of reach of children. If ingested, get medical help or contact a poison control center right away

  • Directions

    Clean affected area

    Apply a small amount 1-3 times daily

    May cover with a sterile bandage

  • Other information

    Store at room temperatuure

  • Inactive ingredients

    Petrolactum, Liquid Paraffin, Octadecanol, Glycerol, Stearic Acid, Purified Water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ROOSIN NEOMYCIN ANTIBIOTIC 
    neomycin sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81552-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN0.556 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    OCTADECANOL (MIXTURE OF ISOMERS) (UNII: C6BPY2QY39)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCEROL FORMAL (UNII: 3L7GR2604E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81552-001-010.9 g in 1 TUBE; Type 0: Not a Combination Product04/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B04/12/2021
    Labeler - ROOSIN MEDICAL CO., LTD (527587815)
    Establishment
    NameAddressID/FEIBusiness Operations
    ROOSIN MEDICAL CO., LTD527587815manufacture(81552-001)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!