Antibiotic
FDA Label NDC 53210-1003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Morales Distributors Inc for the product Antibiotic (NDC 53210-1003). 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 active ingredients (in each gram), purpose, uses, warnings, do not use, consult a doctor in case of, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredients (in Each Gram)

→ Purpose

→ Uses

→ Warnings

→ Do Not Use

→ Consult A Doctor In Case Of

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children

→ Directions

→ Other Information

→ Inactive Ingredients

→ Package Label

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