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  5. Label Information: Triple Antibiotic

FDA Label for Triple Antibiotic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    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. OTHER INFORMATION
    12. INACTIVE INGREDIENT
    13. QUESTIONS?
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Triple Antibiotic Product Label

The following document was submitted to the FDA by the labeler of this product Proficient Rx Lp. 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, USP 400 units

Neomycin sulfate, USP 3.5 mg

Polymyxin B sulfate, USP 5,000 units


Purpose



First aid antibiotic


Uses



Helps prevent infection in

  • •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 the eyes
  • •over 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 unless directed by a doctor

Stop Use And Ask A Doctor If



  • •condition persists or gets worse
  • •a rash or other allergic reaction develops

Keep Out Of Reach Of Children.



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


Directions



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

Other Information



  • •Store at controlled room temperature 59° - 86°F (15° - 30°C).
  • •Protect from freezing.

Inactive Ingredient



White petrolatum


Questions?



1-800-432-8534 between 9 am and 4 pm EST, Monday – Friday.


Package Label.Principal Display Panel



NDC 63187-039-01

Triple Antibiotic Ointment

FIRST AID ANTIBIOTIC

(Bacitracin Zinc-Neomycin Sulfate-Polymyxin B Sulfate Ointment)

First Aid to Help Prevent Infection in Minor Cuts, Scrapes and Burns

Compare to the active ingredients in Neosporin®*

NET WT 1 OZ (28 g)

*This product is not affiliated with, manufactured by, or produced by the makers of Neosporin®.

  •  01791210G1 VC110203

    • Manufactured by: Actavis Mid Atlantic LLC

    1877 Kawai Road, Lincolnton, NC 28092 USA

    Relabeled by:

    Proficient Rx LP

    Thousand Oaks, CA 91320

    63187-039-01 - c7e2f711 figure 01

    63187-039-01 - c7e2f711 figure 01


* Please review the disclaimer below.