VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC- neomycin sulfate ointment

VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC by

Drug Labeling and Warnings

VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC by is a Otc medication manufactured, distributed, or labeled by Compania Internacional de Comercio, S.A.P.I de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each gram)

Neomycin sulfate 5 mg (neomycin 3.5 mg)

Purpose

First aid antibiotic

Uses

First aid to help prevent infection in minor cuts, scrapes, and 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 1 week unless directed by a doctor

Ask a doctor before use if you have

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 the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

store at room temperature

Inactive ingredients

lanolin, methylparaben, petrolatum, propylparaben, vitamin A palmitate

Package Labeling: (

54312-019-35)

Package Labeling: (54312-019-14)

Package Labeling:

Package Labeling:

INGREDIENTS AND APPEARANCE

VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 
neomycin sulfate ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54312-019
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)
METHYLPARABEN (UNII: A2I8C7HI9T)
PETROLATUM (UNII: 4T6H12BN9U)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54312-019-35	1 in 1 CARTON	07/30/2016
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 54312-019-31	1 in 1 CARTON	07/30/2016
2		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333B	07/30/2016

Labeler - Compania Internacional de Comercio, S.A. de C.V. (815039995)

Establishment
Name	Address	ID/FEI	Business Operations
Compania Internacional de Comercio, S.A. de C.V.		815039995	manufacture(54312-019)