Your browser does not support JavaScript! VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (NEOMYCIN SULFATE) OINTMENT [COMPANIA INTERNACIONAL DE COMERCIO, S.A. DE C.V.]
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RxNorm Names

VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC (neomycin sulfate) ointment
[Compania Internacional de Comercio, S.A. de C.V.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

VITACILINA NEOMYCIN SULFATE OINTMENT FIRST AID ANTIBIOTIC


Active Ingredients

Neomycin Sulfate 5 mg (eq to 3.5 mg neomycin)

Purpose

Antibiotic

Uses

First aid to help prevent infection in • minor cuts • scrapes • burns

Warnings

For external use only

•Do not use

in the eyes or apply over large areas of the body.

•In Case of

deep or puncture wounds animal bites or serious burns, consult a doctor.

•Stop use

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

•Do not use

longer than 1 week unless directed by a doctor

Keep out of the reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Clean the affected area. Apply a small amount of the 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.

Inactive ingredients

lanolin, methylparaben, petrolatum, propylparaben, vitamin A palmitate

VITACILINA NEOMYCIN SULFATE OINTMENT FIRST AID ANTIBIOTIC 14g (54312-019-35)| VITACILINA NEOMYCIN SULFATE OINTMENT FIRST AID ANTIBIOTIC 28g (54312-019-31)

Vitacilina Tube LabelBox Label

VITACILINA NEOMYCIN SULFATE FIRST AID ANTIBIOTIC 
neomycin sulfate ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:54312-019
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NEOMYCIN SULFATE (NEOMYCIN) NEOMYCIN3.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
LANOLIN 
METHYLPARABEN 
PETROLATUM 
PROPYLPARABEN 
VITAMIN A PALMITATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54312-019-351 in 1 CARTON
114 g in 1 TUBE
2NDC:54312-019-311 in 1 CARTON
228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333B08/28/2012
Labeler - Compania Internacional de Comercio, S.A. de C.V. (815039995)
Establishment
NameAddressID/FEIBusiness Operations
Farmaqro, S.A. de C.V.588161468manufacture(54312-019)

Revised: 9/2013
 
Compania Internacional de Comercio, S.A. de C.V.

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