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  5. Label Information: Sheffield Triple Antibiotic Plus Pain Relief

FDA Label for Sheffield Triple Antibiotic Plus Pain Relief

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENTS (IN EACH GRAM)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. ALLERGY ALERT:
    7. DO NOT USE
    8. CONSULT A DOCTOR BEFORE USE IF YOU HAVE
    9. WHEN USING THIS PRODUCT
    10. STOP USE AND CONSULT A DOCTOR IF
    11. OTC - KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER INFORMATION
    14. INACTIVE INGREDIENT
    15. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sheffield Triple Antibiotic Plus Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Sheffield Pharmaceuticals Llc. 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.

Other



Drug Facts


Active Ingredients (In Each Gram)



Bacitracin 500

Neomycin 3.5 mg

Polymyxin B 10,000 units

Pramoxine hydrochloride 10mg


Purpose



First aid antibiotic

First aid antibiotic

First aid antibiotic

Pain reliever


Uses



helps prevent infection in and temporarily relieves pain due to:

  • cuts
  • scrapes
  • burns

Warnings



For external use only


Allergy Alert:



  • do not use if you are allergic to any of the ingredients

Do Not Use



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

Consult 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 Consult 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



Keep out of the reach of children. If swallowed get medical help or contact a Poison Control Center immediately.


Directions



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

Other Information



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

Inactive Ingredient



Petrolatum


Package Label.Principal Display Panel




Principal Display Panel – Carton Label

Dr. Sheffield's NDC 11527-161-55

Triple Antibiotic Plus Pain Relief 
Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate •  Pramoxine HCL             
First Aid Antibiotic  Plus Pain Relieving Ointment

NET WT. 1 oz. (28g)


Principal Display Panel – Tube Label

Dr. Sheffield's NDC 11527-161-55

Triple Antibiotic Plus Pain Relief

Bacitracin Zinc • Neomycin Sulfate • Polymyxin-B Sulfate • Pramoxine HCL    
First Aid Antibiotic/Pain Relieving Ointment

NET WT. 1 oz. (28g)
First Aid Treatment for Minor Cuts, Scrapes and Burns


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