Label: MAKESENSE FIRST AID- bacitracin zinc neomycin polymyxin b 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 August 8, 2016

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

View All Sections
  • Active ingredients

    Bacitracin Zinc 400U

    Neomycin 3.5 mg

    Polymyxin B sulfate 5000U

  • Purpose

    First Aid Antibiotic

    First Aid Antibiotic

    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 ■ if you are allergic to any of the ingredients ■ longer than 1 week unless directed by a doctor ■ over large areas of the body

  • Ask a doctor before use

    ■ on deep puncture wounds, animal bites, or serious burns

  • Stop use and consult a doctor if

    ■ the condition persists worsens ■ a rash or other allergic reaction develops

  • Keep out of reach of children

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

  • Directions

    ■ clean the affected area and dry thoroughly ■ apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily ■ may be covered with a sterile bandage

  • Other Information

    ■ store at room temperature 68 to 77F (20to 25C) ■ see carton or tube crimp for lot number and expiration date

  • Inactive ingredients

    Methylparaben, Mineral Oil, Ozocerite, Petrolatum, Propanediol, Propylparaben

  • Package Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    MAKESENSE  FIRST AID
    bacitracin zinc neomycin polymyxin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69020-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [USP'U]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69020-202-1414 g in 1 TUBE; Type 0: Not a Combination Product06/15/2014
    2NDC:69020-202-099.3 g in 1 TUBE; Type 0: Not a Combination Product06/15/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B06/15/2014
    Labeler - Cherry Hill Sales Co (145959768)
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!