Vitacilina Neomycin Sulfate First Aid Antibiotic Ointment
FDA Label NDC 54312-019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Compania Internacional De Comercio, S.a.p.i De C.v. for the product Vitacilina Neomycin Sulfate First Aid Antibiotic (NDC 54312-019). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient (in each gram), purpose, uses, warnings, do not use, ask a doctor before use if you have, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
* Please review the disclaimer below.
