Label: TRIPLE ANTIOBIOTIC- triple antibiotic ointment 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 February 1, 2019

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

View All Sections
  • DOSAGE & ADMINISTRATION

    DIRECTIONS

    • clean affected area
    • apply small amount not more than 3 times daily
    • maybe covered with a sterile bandage
    • children under 2 years of age ask a doctor
  • INDICATIONS & USAGE

    USES

    First aid to help prevent infection and for the temporary relief of pain and itching associated with minor cuts, scrapes and burns

  • WARNINGS

    FOR EXTERNAL USE ONLY

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    If ingested contact a poison control center right away.

  • ACTIVE INGREDIENT

    NEOMYCIN

    BACITRACIN

    PRAMOXINE HCI

  • INACTIVE INGREDIENT

    Petrolatum

  • PURPOSE

    First Aid Antibiotic. For temporary relief of pain associated with minor burns.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TRIPLE ANTIOBIOTIC 
    triple antibiotic ointment ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN5 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN400 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70897-003-010.9 g in 1 PACKET; Type 0: Not a Combination Product08/11/2016
    2NDC:70897-003-0214.2 g in 1 TUBE; Type 0: Not a Combination Product08/11/2016
    3NDC:70897-003-0328.4 g in 1 TUBE; Type 0: Not a Combination Product08/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/11/2016
    Labeler - Davemed Healthcare Co., Ltd. (529128716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davemed Healthcare Co., Ltd.529128716manufacture(70897-003)
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!