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  5. Label Information: Antibiotic Application

FDA Label for Antibiotic Application

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT:
    2. PURPOSE:
    3. USE:
    4. WARNINGS:
    5. KEEP OUT OF REACH OF CHILDREN.
    6. DO NOT USE:
    7. DIRECTIONS:
    8. INACTIVE INGREDIENT:
    9. ACTIVE INGREDIENTS (IN EACH GRAM)
    10. PURPOSE
    11. USE
    12. WARNINGS
    13. DO NOT USE
    14. ASK A DOCTOR BEFORE USE IF YOU HAVE
    15. STOP USE AND ASK A DOCTOR IF
    16. DIRECTIONS
    17. INACTIVE INGREDIENTS
    18. ANTISEPTIC TOWELETTES (49687-0016-0) LABELING:
    19. ANTIBIOTIC APPLICATION (49687-0013-0) LABELING:
    20. REFILL 2 (49687-0016-0) LABELING:

Antibiotic Application Product Label

The following document was submitted to the FDA by the labeler of this product Cmc Group, 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 Ingredient:



Benzalkonium Chloride 0.13%


Purpose:



First Aid Antiseptic


Use:



For Professional and Hospital use. Helps prevent infection. Antiseptic cleansing of face, hands and body without soap and water.


Warnings:



For external use only.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center right away. If unusual redness, swelling or other symptoms occur, consult a physician immediately.

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


Do Not Use:



In the eyes, or over large areas of the body.


Directions:



Tear open packet, unfold towelette and use to cleanse desired skin area. Discard towelette appropriately after single use.


Inactive Ingredient:



Purified water.


Active Ingredients (In Each Gram)



Bacitracin zinc (bacitracin 400 units)
Neomycin sulfate (neomycin 3.5mg)
Polymyxin B sulfate (polymyxin B 5,000 units)


Purpose



First aid antibiotic


Use



  • First aid to help prevent infection in minor cuts, scrapes, and burns.

Warnings



For external use only


Do Not Use



• in the eyes • over large areas of the body • if you are allergic to any of the ingredient • longer than 1 week unless directed by a doctor.


Ask A Doctor Before Use If You Have



• deep or punture wounds • animal bites • serious burns.


Stop Use And Ask A Doctor If



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


Directions



• Clean the affected area. • Apply a small amount of this product (an 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.


Inactive Ingredients



Mineral oil, petrolatum, purified water


Antiseptic Towelettes (49687-0016-0) Labeling:



Towelettes - Towelettes

Towelettes - Towelettes


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