ANTIBIOTIC OINTMENT- neomycin sulfate ointment

Antibiotic Ointment by

Drug Labeling and Warnings

Antibiotic Ointment by is a Otc medication manufactured, distributed, or labeled by NeoPharm Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 Ointment

INGREDIENTS AND APPEARANCE

ANTIBIOTIC OINTMENT 
neomycin sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51141-0066
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297)	NEOMYCIN SULFATE	3.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PARAFFIN (UNII: I9O0E3H2ZE)
SQUALANE (UNII: GW89575KF9)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51141-0066-1	1 in 1 BOX
1		28 g in 1 TUBE

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	Business Operations
NeoPharm Co., Ltd.		631101883	manufacture