Label: BACITRAYCIN PLUS- bacitracin zinc and pramoxine hydrochloride 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 October 8, 2020

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  • ACTIVE INGREDIENT

    Active ingredients (in each gram) Purposes

    Bacitracin zinc 500 units............First aid antibiotic

    Parmoxine HCl 10 mg...............External analgesic

  • PURPOSE

    Uses

    • first aid to help prevent infection and for the temporary relief of pain in minor:
    • cuts
    • scrapes
    • burns
  • WARNINGS

    For external use only

  • DO NOT USE

    Do no use

    • if you are allergic to any of the ingredients
    • in the eyes
    • over large areas of the body or bandage
  • 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
    • symptoms persist for more than 1 week, or clear up and occur again within a few days
    • condition persists or gets worse
    • redness, irritation, swelling, or pain persists or increases
    • rash or other allergic reactin 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

    • adults and children 2 years of age and older:
    • clean the affected area
    • 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
    • children under 2 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

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

    Inactive ingredients aloe vera oil, petrolatum

  • DOSAGE & ADMINISTRATION

    Dirtributed by:

    FIRST AID RESEARCH CORP.

    Jupiter, FL 33478 Made in China

  • PRINCIPAL DISPLAY PANEL

    cartoncarton

  • INGREDIENTS AND APPEARANCE
    BACITRAYCIN PLUS 
    bacitracin zinc and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-056
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75983-056-011 in 1 BOX01/09/2019
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:75983-056-021 in 1 BOX01/09/2019
    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 finalpart333B01/09/2019
    Labeler - First Aid Research Corp (089405927)
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