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Antibiotic

Morales Distributors Inc

Antibiotic Ointment


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients (in each gram)

Neomycin Sulfate 3.5mg

Purpose

First aid antibiotic

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

Antibiotic 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

Antibiotic
Antibiotic
Antibiotic

Antibiotic

NEOMYCIN SULFATE OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53210-1003
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Neomycin Sulfate NEOMYCIN 3.5 mg

Inactive Ingredients

Ingredient Name Strength
Mineral Oil
SQUALANE
LANOLIN
petrolatum
CETOSTEARYL ALCOHOL
.ALPHA.-TOCOPHEROL ACETATE
METHYLPARABEN
PROPYLPARABEN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28 in 1 TUBE
2 NDC:53210-1003-0 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partB part333B 2012-09-25


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Be sure to consult your doctor before taking any medication!
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