ANTIBIOTIC- neomycin sulfate ointment

Antibiotic by

Drug Labeling and Warnings

Antibiotic by is a Otc medication manufactured, distributed, or labeled by Morales Distributors Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ANTIBIOTIC  
neomycin sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53210-1003
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
MINERAL OIL (UNII: T5L8T28FGP)
SQUALANE (UNII: GW89575KF9)
LANOLIN (UNII: 7EV65EAW6H)
PETROLATUM (UNII: 4T6H12BN9U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53210-1003-0	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	09/25/2012

Labeler - Morales Distributors Inc (127151731)