Your browser does not support JavaScript! ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [MORALES DISTRIBUTORS INC]
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RxNorm Names

ANTIBIOTIC (neomycin sulfate) ointment
[Morales Distributors Inc]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

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

package box label

tube label

ANTIBIOTIC  
neomycin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:53210-1003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL 
SQUALANE 
LANOLIN 
PETROLATUM 
CETOSTEARYL ALCOHOL 
.ALPHA.-TOCOPHEROL ACETATE 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53210-1003-01 in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B09/25/2012
Labeler - Morales Distributors Inc (127151731)

Revised: 9/2012
 
Morales Distributors Inc

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