VITACILINA- neomycin ointment

Vitacilina by

Drug Labeling and Warnings

Vitacilina by is a Otc medication manufactured, distributed, or labeled by Teresa Cecena DBA Genesis, Teresa Cecena, Farmaqro SA de CV. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

NEOMYCIN SULFATE 5mg

PURPOSE

PURPOSE

Antibootic

USER SAFETY WARNINGS

USES

Frist aid to help prevent infection in* minor cuts*scrapes*burns

WARNINGS

Warnings

For external Use only

DO NOT USE

DO NOT USE

In the eyes or apply over large areas of the body

Longer that a weel unless directed by doctor

STOP USE

Stop Use

And consult a doctor if the condition persists or gets worse, or if a rash or other allergic reaction develops

KEEP OUT OF REACH OF CHILDREN

In case of accidental ingestion, seek professional assistance or contac a poison control center immediately.

DOSAGE & ADMINISTRATION

Directions

Clean the affected area. Apply a small amout of the product ( an amount equeal to the surface area of the tip of finger) on the area 1 to 3 times daily. May be covered with a sterile bandage.

INDICATIONS & USAGE

Clean the affected area. Aplly a small amount of the product on the area 1 to 3 times daily.

May be covered with a sterile bandage

INACTIVE INGREDIENT

Lanolin, Methylparaben, Petrolatum, propylparaben, vitamin A palmitate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

VITACILINA 
neomycin ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69772-019
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)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69772-019-35	1 in 1 CARTON	05/15/2015
1		14 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 69772-019-31	1 in 1 CARTON	05/20/2015
2		28 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 69772-019-32	1 in 1 CARTON	02/03/2017
3		32 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	05/15/2015

Labeler - Teresa Cecena DBA Genesis (078760958)

Registrant - Teresa Cecena (078760958)

Establishment
Name	Address	ID/FEI	Business Operations
Teresa Cecena DBA Genesis		078760958	relabel(69772-019)

Establishment
Name	Address	ID/FEI	Business Operations
Farmaqro SA de CV		588161468	manufacture(69772-019)