Label: FAMILY CARE FIRST AID- 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 May 16, 2022

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

View All Sections
  • ACTIVE INGREDIENT

    Active ingredient (in each gram) Purpose

    Bacitracin Zinc 500 units..............................................First aid antibiotic

  • PURPOSE

    Uses

    • first aid to help prevent infection in minor:
    • cuts
    • scrapes
    • burns
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body
  • ASK DOCTOR

    Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • you need to use longer than 1 week
    • condition persists or gets worse
    • rash or other allergic reaction develops
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • clean the affected area
    • apply a small amount of this product (an amount 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
  • STORAGE AND HANDLING

    Other information

    store at room temperature 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera leaf extract, ethyl alcohol, light mineral oil, methylparaben, petrolatum stearyl alcohol

  • DOSAGE & ADMINISTRATION

    Distributed by: United Exchange Corp.

    Cypress, CA 90630 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    496A

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE FIRST AID 
    bacitracin zinc ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-491
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ALCOHOL (UNII: 3K9958V90M)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-491-331 in 1 CARTON05/17/2022
    19.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B05/17/2022
    Labeler - United Exchange Corp. (840130579)
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!