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  5. Label Information: Antibiotic

FDA Label for Antibiotic

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS (IN EACH GRAM)
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. CONSULT A DOCTOR IN CASE OF
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL

Antibiotic Product Label

The following document was submitted to the FDA by the labeler of this product Morales Distributors 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)



Neomycin Sulfate 3.5mg


Purpose



First aid antibiotic


Uses



First aid to help prevent infection in minor:

  • cuts
  • scrapes
  • 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 ingredients
  • longer than one week unless directed by a doctor

Consult A Doctor In Case Of



  • deep or puncture 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

Keep Out Of Reach Of Children



in case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.


Directions



  • adults and children 2 years of age and older
  • 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
  • children under 2 years of age: ask a doctor

Other Information



store at room temperature


Inactive Ingredients



Liquid paraffin, Cethanol, Squalane, Purified lanolin, White petrolatum, Cetearyl alcohol, Tocopheryl acetate, Methylparaben, Propylparaben


Package Label



NDC NO. 53210-1003-0
Compare to Vitacilinia First Aid Antibiotic active ingredient

MAXIMUM STRENGTH

ANTIBIOTIC OINTMENT
Neomycin Sulfate
FIRST AID ANTIBIOTIC OINTMENT

Net 1 oz (28.3g)

Exclusively distributed by:
Morales Distributors, Inc.
Mayaguez, P.R. 00682

Made in Korea

package box label - box1

package box label - box1





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