Label: CAREALL TRIPLE ANTIBIOTIC PLUS PAIN RELIEF- bacitracin zinc, neomycin sulfate, polymyxin 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 August 23, 2019

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  • Active Ingredients (in each gram)

    Bacitracin Zinc 500 units

    Neomycin Sulfate 3.5 mg

    Polymyxin B Sulfate 10,000 units

    Pramoxine HCl 10mg

  • PURPOSE

    First aid antibiotic (Bacitracin Zinc 500 units, Neomycin Sulfate 3.5 mg, & Polymyxin B Sulfate 10,000 units)

    External Analgesic (Pramoxine HCl 10mg)

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center immediately

  • INDICATIONS & USAGE

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

  • WARNINGS

    For external use only

    Do not use

    In the eyes

    If you are allergic to any of the ingredients

    Over large areas of the body

    Ask a doctor before use if you have

    Animal bites

    Serious Burns

    Deep or puncture wounds

    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

    symptoms persist for more than 1 week, or clear up and occur again within a few days

  • DOSAGE & ADMINISTRATION

    Adults and childre 2 years of age and older:

    • Clean the affected area
    • Apply a small amount of this product (an amount equal to the surface of th tip of a finger) on the area 1 to 3 times daily
    • May be covered with a sterile bandage

    Children under 2 years of age: ask a doctor

  • INACTIVE INGREDIENT

    White Petrolatum

  • PRINCIPAL DISPLAY PANEL

    Triple Plus Carton

  • INGREDIENTS AND APPEARANCE
    CAREALL TRIPLE ANTIBIOTIC PLUS PAIN RELIEF 
    bacitracin zinc, neomycin sulfate, polymyxin b sulfate, pramoxine hcl ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN500 [USP'U]  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 [USP'U]  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-073-0128 g in 1 TUBE; Type 0: Not a Combination Product09/02/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B09/02/2019
    Labeler - New World Imports, Inc (075372276)
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