Label: CUADRIDERMA- bacitracin zinc, polymyxin b sulfate, neomycin sulfate, and pramoxine hydrochloride 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 January 25, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredients (in each gram)Purpose
    Bacitracin 500 unitsFirst aid antibiotic
    Neomycin 3.5 mgFirst aid antibiotic
    Polymyxin B 10,000 unitsFirst aid antibiotic
    Pramoxine hydrochloride 10 mgPain reliever
  • Uses

    helps prevent infection in and temporarily relieves pain due to

    *
    minor cuts
    *
    scrapes
    *
    burns
  • Warnings

    For external use only

    Allergy alert

    *
    do not use if allergic to any of the ingredients

    Do not use

    *
    in or near the eyes
    *
    on large areas of the body

    Ask a doctor before use if you have

    *
    deep or puncture wounds
    *
    animal bites
    *
    serious burns

    When using this product

    *
    do not use longer than 1 week

    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 2 years and older:

    *
    clean affected area
    *
    apply a small amount (equal to surface area of tip of finger) on area 1 to 3 times daily.
    *
    may be covered with sterile bandage.

    Children under 2 years: ask a doctor

  • Other information

    Store at controlled room temperature 68°-77°F (20°-25°C)

  • Inactive ingredient

    Petrolatum

  • Questions Comments

    1 (305) 653-2700

  • PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton

    Original

    Cuadriderma®
    First Aid Antibiotic / Pain Relief Ointment

    Net Wt. 1 oz (28.35 g.)

    Pro-Mex®

    PRINCIPAL DISPLAY PANEL - 28.35 g Tube Carton
  • INGREDIENTS AND APPEARANCE
    CUADRIDERMA 
    bacitracin zinc, polymyxin b sulfate, neomycin sulfate, and pramoxine hydrochloride ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58988-1170
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Bacitracin Zinc (UNII: 89Y4M234ES) (Bacitracin - UNII:58H6RWO52I) Bacitracin500 [iU]  in 1 g
    Polymyxin B Sulfate (UNII: 19371312D4) (Polymyxin B - UNII:J2VZ07J96K) Polymyxin B10000 [iU]  in 1 g
    Neomycin Sulfate (UNII: 057Y626693) (Neomycin - UNII:I16QD7X297) Neomycin3.5 mg  in 1 g
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Petrolatum (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58988-1170-11 in 1 CARTON05/31/2013
    128.35 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333B05/31/2013
    Labeler - ProMex LLC (789974388)
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