Label: FIRST AID MAXIMUM STRENGTH BACITRAYCIN PLUS- bacitracin, and pramoxine hcl 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 March 1, 2018

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  • ACTIVE INGREDIENT

    Active ingredients (each gram contains) Purpose

    Bacitracin 500 units.......................................................................................................First Aid Antibiotic

    Pramoxine HCI 10 mg..................................................................................................Pain Reliever

  • 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

    • in the eyes
    • if you are allergic to any of the ingredients
    • over large areas of the body
    • longer than 1 week unless directed by a doctor
  • ASK DOCTOR

    Ask a doctor before use in case of deep or puncture wounds, animal bites, or serious burns

  • 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 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
  • STORAGE AND HANDLING

    Other information

    • store at 15° to 25°C (59° to 77°F)
    • lot no. & exp. date: see box or see crimp of tube
  • INACTIVE INGREDIENT

    Inactive ingredients

    aloe vera leaf, methylparaben, mineral oil, petrolatum, propylparaben, stearyl alcohol

  • DOSAGE & ADMINISTRATION

    Distributed by:

    First Aid Research Corp.

    Jupiter, FL 33478

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    49555

  • PRINCIPAL DISPLAY PANEL

    89884V

  • INGREDIENTS AND APPEARANCE
    FIRST AID MAXIMUM STRENGTH BACITRAYCIN PLUS 
    bacitracin, and pramoxine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75983-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75983-055-281 in 1 CARTON03/01/2018
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/01/2018
    Labeler - First Aid Research Corp (089405927)
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