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Name:Antibiotic Ointment
Manufacturer:Neopharm Co., Ltd.
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ANTIBIOTIC OINTMENT  - neomycin sulfate ointment 
NeoPharm Co., Ltd.

Disclaimer: 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.

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Drug Facts

Active ingredient (in each gram)

Neomycin Sulfate 3.5mg

Purposes

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 finer) 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

Antibiotic Ointmentimage of caton label


ANTIBIOTIC OINTMENT 
neomycin sulfate ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:51141-0066
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN SULFATE 3.5 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
PARAFFIN  
SQUALANE  
LANOLIN  
PETROLATUM  
CETOSTEARYL ALCOHOL  
.ALPHA.-TOCOPHEROL ACETATE, D-  
METHYLPARABEN  
PROPYLPARABEN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:51141-0066-1 1 TUBE ( TUBE) in 1 BOX contains a TUBE
1 28 g in 1 TUBE This package is contained within the BOX (51141-0066-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333B 08/26/2010

Labeler - NeoPharm Co., Ltd. (631101883)
Registrant - NeoPharm Co., Ltd. (631101883)
Establishment
Name Address ID/FEI Operations
NeoPharm Co., Ltd. 631101883 manufacture

Revised: 08/2010 NeoPharm Co., Ltd.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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