Label: ATOPALM FIRST AID TRIPLE ANTIBIOTIC- bacitracin zinc, neomycin sulfate, polymycin b sulfate 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 November 9, 2011

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  • Active Ingredients (in each gram)

    Bacitracin Zinc 400 units

    Neomycin Sulfate 3.5mg

    Polymycin B Sulfate 5000 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

    if you are allergic to any of the ingredients

    in the eyes

    over large areas of the body

    for longer than 1 week unless director by a doctor

    Ask a doctor before use if you have

    deep or puncture wounds

    animal bites

    serious burns

    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

  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center immediately

  • Directions

    clean the affected area

    apply a small amount of the 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

    children under 2 yrs. of age ask a doctor

  • Other Information

    store between 20 to 25 C (69 to 77F

    see end of carton or tube crimp for lot number and expiration date.

  • Inactive Ingredients

    Petrolatum, Mineral Oil, Glycerin, Cetyl Alcohol, Steareth-2, Stearic Acid, Cholesterol, Myristoyl/Palmitoyl Oxostearamide/Archamide MEA, Squalene, Tocopheryl Acetate

  • Questions?

    Call 1-855-ATOPALM

  • PRINCIPAL DISPLAY PANEL

    First Aid Protection in a moisturizing ointment based on US Patented Technology                       

       Relief with Maximum, Soothing Moisture



    ATOPALM
    FIRST AID TRIPLE ANTIBIOTIC

    First Aid protection in a Moisturizing Ointment Based on US Patented MLE Technology

    Effective Infection Protection for cuts, scrapes and burns


    ATOPALM
    Soothes and Moisturizes
    Suitable for use by adults and children

    Bacitracin Zinc - Neomycin Sulfate - Polymycin B Sulfate

    Net wt. 1oz/28.3g


    Distributed by: NeoPharm Co., Ltd 80 Wood Rd, 212 Camarillo, CA 93010

    Made in Korea

  • PRINCIPAL DISPLAY PANEL

    ATOPALM First Aid Antibiotic

  • PRINCIPAL DISPLAY PANEL

    ATOPALM First Aid Antibiotic

  • INGREDIENTS AND APPEARANCE
    ATOPALM FIRST AID TRIPLE ANTIBIOTIC  
    bacitracin zinc, neomycin sulfate, polymycin b sulfate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-3000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE3.5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    SQUALENE (UNII: 7QWM220FJH)  
    ACETATE ION (UNII: 569DQM74SC)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-3000-11 in 1 CARTON
    128.3 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B03/16/2011
    Labeler - Neopharm Co., Ltd. (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture
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