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  5. Label Information: Triple Antibiotic Plus Maximum Strength

FDA Label for Triple Antibiotic Plus Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. OTC - WHEN USING THIS PRODUCT
    8. OTC - STOP USE AND ASK A DOCTOR IF
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. 2  DOSAGE & ADMINISTRATION
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENT
    13. OTC - QUESTIONS OR COMMENTS?
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Antibiotic Plus Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product The Kroger Co.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



(in each gram)

Bacitracin zinc, USP 500 units

Neomycin Sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 10,000 units

Pramoxine hydrochloride, USP 10 mg


Otc - Purpose



First aid antibiotic/Pain reliever


Uses



First aid to help prevent infection and for temporary relief of pain or discomfort due to

  • minor cuts
  • scrapes
  • burns

Warnings



For external use only

Allergy alert:

  • do not use if allergic to any of the ingredients

Otc - Do Not Use



  • in the eyes
  • over large areas of the body

Otc - Ask A Doctor Before Use If You Have



  • deep or puncture wounds
  • animal bites
  • serious burns[/S][/S][/S]

Otc - When Using This Product



  • do not use longer than 1 week unless directed by a doctor

Otc - Stop Use And Ask A Doctor If



  • condition persists 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 develops

Otc - Keep Out Of Reach Of Children



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


2  Dosage & Administration



Adults and children 2 years and older:

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

    • Children under 2 years: ask a doctor


Other Information



  • Store at 59° -86°F (15° -30°C).
  • Before using any medication, read all label directions. Keep carton, it contains important information.

Inactive Ingredient



White petrolatum


Otc - Questions Or Comments?



1-800-632-6900


Package Label.Principal Display Panel



Kroger®

QUALITY GUARANTEED

Compare to the active ingredients of NEOSPORIN® PLUS.

*See Back Panel.

maximum strength

TRIPLE ANTIBIOTIC OINTMENT

PLUS PAIN RELIEF

• Bacitracin Zinc • Neomycin Sulfate • Polymyxin B Sulfate • Pramoxine Hydrochloride

• First aid antibiotic plus topical pain reliever

NET WT 1 OZ (28 g)

08230611xx VC108014

* Please review the disclaimer below.