Label: CVS BACITRACIN WITH PAIN RELIEF- bacitracin and lidociane 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 August 2, 2011

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  • ACTIVE INGREDIENT

    Active ingredient                                               Purpose

    Bacitracin, USP 500 units..................................................First Aid Antibiotic
    Lidocaine 4% w/w..............................................................Pain Reliever
  • PURPOSE



    Uses

    - first aid to help prevent infection in and temporarily relieve pain due to
    - minor cuts  - scrapes  - burns
  • KEEP OUT OF REACH OF CHILDREN


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

  • INDICATIONS & USAGE



    Uses

    - first aid to help prevent infection in and temporarily relieve pain due to
    - minor cuts  - scrapes  - burns
  • WARNINGS

    Warnings

    For external use only

    Do not use - in the eyes - over large areas of the body
                       - if you are allergic to any of the ingredients
                       - longer than 1 week unless directed by a doctor

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

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

    Keep out of reach of children.     If swallowed, get medical help or contact a
    Poison Control Center right away.
  • DOSAGE & ADMINISTRATION


    Directions

    Adults and children 2 years 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
    - may be covered with a sterile bandage

    Children under 2 years ask a doctor


  • INACTIVE INGREDIENT

    Inactive Ingredients


    white petrolatum

  • PRINCIPAL DISPLAY PANEL


    c


  • INGREDIENTS AND APPEARANCE
    CVS BACITRACIN WITH PAIN RELIEF 
    bacitracin and lidociane ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-537
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN (UNII: 58H6RWO52I) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN600 [USP'U]  in 1 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-537-111 in 1 CARTON
    114 g in 1 TUBE
    2NDC:59779-537-5510 in 1 CARTON
    21 g in 1 DOSE PACK
    3NDC:59779-537-5415 in 1 CARTON
    31 g in 1 DOSE PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B07/08/2010
    Labeler - CVS Pharmacy (062312574)
    Registrant - Pharma Pac, LLC (140807475)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Pac, LLC140807475manufacture
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