Label: ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymycin b sulfate, 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 June 17, 2015

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  • ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING OINTMENT AND PAIN RELIEF


  • Active Ingredients (each gram contains)

    Bacitracin Zinc 500 units

    Neomycin Sulfate 3.5mg

    Polymycin B Sulfate 10,000 units

    Pramoxine HCl 10mg

  • Purpose



    First Aid Antibiotic
    Topical Analgesic

  • Uses

    First aid to help prevent infection and for the temporary relief of pain and discomfort of minor cuts, scrapes, burns.

  • Warnings

    For external use only

    Do not use

    • if you are allergic to any of the ingredients
    • in or near the eyes
    • longer than 1 week
    • over large areas of the body

    Ask a doctor before use

    • on deep or puncture wounds, animal bites or serious burns

    Stop use and ask a doctor if

    • condition gets worse
    • condition persists for more than 7 days
    • condition clears up and occurs again within a few days
    • a rash or other allergic reaction develops.
  • Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 2 years of age and older

    • clean the affected area and dry throughly
    • apply a small 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

    • Consult a doctor.
  • Other Information

    • store at 68° – 77°F (20° – 25°C)
    • see carton flap or tube crimp for lot number and expiration date
  • Inactive Ingredients

    PETROLATUM, LIGHT MINERAL OIL, STEARIC ACID, CHOLESTEROL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHMIDE MEA.

  • Questions or information call toll free:

    Call 1-855-ATOPALM

  • PRINCIPAL DISPLAY PANEL


    AtopalmMoisturizingFirstAidTripleAntibioticProtection

    AtopalmMoisturizingFirstAidTripleAntibioticProtectionInner

  • INGREDIENTS AND APPEARANCE
    ATOPALM FIRST AID TRIPLE ANTIBIOTIC PROTECTION MOISTURIZING AND PAIN RELIEF  
    bacitracin zinc, neomycin sulfate, polymycin b sulfate, pramoxine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51141-0238
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (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 B10000 [iU]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51141-0238-11 in 1 CARTON
    128.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/08/2012
    Labeler - Neopharm Co., Ltd. (965502912)
    Establishment
    NameAddressID/FEIBusiness Operations
    NeoPharm Co., Ltd.631101883manufacture(51141-0238)
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