Label: GERIGENTLE-BACITRACIN ZINC- bacitracin zinc 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 30, 2021

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

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (In each gram)

    Bacitracin Zinc (equal to 500 Bacitracin Units)

  • Purpose

    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 7 days unless directed by a physician

    Consult a doctor before use in cases of

    • Deep or puncture wounds
    • Animal Bites
    • Serious Burns

    Stop usage and consult a doctor if

    • Conditions persist or get worse
    • Rash or other allergic reaction develops

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center immediately
  • Directions for Use

    • Clean the affected area
    • Apply a small amount of this product 1-3 times daily (an amount equal to the surface area of a fingertip)
    • May be covered with a sterile bandage
  • Other information

    • Store at 15°-30°C (59°-86°F)
    • Avoid excessive heat and humidity
  • Inactive Ingredients

    Hard Paraffin, Liquid Paraffin, White Soft Paraffin and Lanolin

  • PRINCIPAL DISPLAY PANEL

    Principal Display and Drug Fact Panel

  • INGREDIENTS AND APPEARANCE
    GERIGENTLE-BACITRACIN ZINC 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-106
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PARAFFIN (UNII: I9O0E3H2ZE)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69771-106-34144 in 1 BOX01/15/2015
    10.9 g in 1 PACKET; Type 0: Not a Combination Product
    2NDC:69771-106-351 in 1 CARTON01/15/2015
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/15/2015
    Labeler - Geri-Gentle Corporation (080367686)
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!