Label: FONOW- bacitracin, neomycin, polymyxin b, lidocaine hcl ointment

  • NDC Code(s): 52454-001-01, 52454-001-02
  • Packager: Zhejiang Fonow Medicine Co., Ltd
  • 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 27, 2020

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  • SPL UNCLASSIFIED SECTION

    FONOW
    Triple Antibiotic Ointment
    With Pain Relief

  • Active ingredients (in each gram)

    Bacitracin 500 units

    Neomycin 3.5mg

    Polymyxin B 5000 units

    Lidocaine HCL 40 mg

  • Purpose

    First aid antibiotic

    First aid antibiotic

    First aid antibiotic

    Anesthetic

  • INDICATIONS & USAGE

    Uses Fist aid to help prevent infection and provide temporary pain relief in minor cuts scrapes burns

  • Warnings

    For external use only.

  • Do not use

    if allergic to any of the ingredients
    in or near the eyes
    over large areas of the body

  • STOP USE

    Stop use and ask a doctor if
    condition lasts or gets worse
    symptoms last for more than 7 days or clear up and come back within a few days
    a rash or other allergic reaction occurs

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    Adults and children 2yrs. and older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily. may be cover with a sterile bandage
    Children under 2: ask a doctor

  • Inactive ingredient

    White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    Drug Facts
    Active ingredients (in each gram) Purpose
    Bacitracin 500 units .....................................................First aid antibiotic
    Neomycin 3.5mg ............................................................First aid antibiotic
    Polymyxin B 5000 units..................................................First aid antibiotic
    Lidocaine Hcl 40 mg........................ .... .... ... ........................ Anesthetic

    Uses Fist aid to help prevent infection and provide temporary pain relief in minor cuts scrapes burns

    Warnings
    For external use only.
    Do not use
     if allergic to any of the ingredients
     in or near the eyes
     over large areas of the body
    Ask a doctor before use if you have
     deep or puncture wounds
     animal bites
     serious burns
    Stop use and ask a doctor if
     condition lasts or gets worse
     symptoms last for more than 7 days or clear up and come back within a few days
     a rash or other allergic reaction occurs
    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
    Directions
     Adults and children 2yrs. and older: apply amount (equal to the surface area of a fingertip) on area 1 to 3 times daily. may be cover with a sterile bandage
     Children under 2: ask a doctor
    Other information Store at temperature 50°-86℉(10°-30℃)
    Inactive ingredient White Petrolatum

    Labeling of pouch box

    Labeling of tube box

  • INGREDIENTS AND APPEARANCE
    FONOW 
    bacitracin, neomycin, polymyxin b, lidocaine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52454-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B5000 [iU]  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U) 945 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52454-001-01100 in 1 BOX01/01/2018
    11 g in 1 POUCH; Type 0: Not a Combination Product
    2NDC:52454-001-021 in 1 BOX01/01/2018
    215 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B01/01/2018
    Labeler - Zhejiang Fonow Medicine Co., Ltd (420094818)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Fonow Medicine Co., Ltd420094818manufacture(52454-001)