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  5. Label Information: Antibiotic And Pain Relief Maximum Strength

FDA Label for Antibiotic And Pain Relief Maximum Strength

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSES
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR BEFORE USE IF YOU HAVE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. INACTIVE INGREDIENT
    12. QUESTIONS?
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Antibiotic And Pain Relief Maximum Strength Product Label

The following document was submitted to the FDA by the labeler of this product Kinray, Inc.. 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.

Active Ingredients



(in each gram)

Bacitracin zinc 500 units

Neomycin 3.5 mg

Polymyxin B sulfate 10,000 units

Pramoxine hydrochloride 10 mg


Purposes



First aid antibiotic/Pain 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 right away.


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 a sterile bandage

    • Children under 2 years: ask a doctor


Inactive Ingredient



White petrolatum


Questions?



1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday-Friday.

Store at 59° - 86°F (15° - 30°C).


Package Label.Principal Display Panel



*Compare to the active ingredients in Neosporin®+ Pain Relief

Preferred plus ++++ Pharmacy

ANTIBIOTIC + PAIN RELIEF

MAXIMUM STRENGTH OINTMENT

BACITRACIN ZINC – NEOMYCIN SULFATE - POLYMYXIN B SULFATE - PRAMOXINE HCl

FIRST AID ANTIBIOTIC /PAIN RELIEVING OINTMENT

NET WT 1 OZ (28 G)

INFECTION PROTECTION

FOR BURNS, CUTS & SCRAPES

Maximum Strength Pain Relief Ointment

08230209A1 VC109276

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CARTON LABEL

* Please review the disclaimer below.