Antibiotic
FDA Label NDC 58988-0038

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Promex, Llc for the product Antibiotic (NDC 58988-0038). 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 ingredient (in each gram), purposes, 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 Ingredient (In Each Gram)

Neomycin 3.5mg

Purposes

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 woundsanimal bitesserious burns

Stop Use And Ask A Doctor If

the condition persists or gets worsea rash or other allergic reaction occurs

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 finer) on the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • children under 2 years of age:  ask a doctor

Other Information

  • store at room temperature

Inactive Ingredients

Cetyl alcohol, Light Mineral Oil, Methylparaben, Propylparaben, Squalane, Tocopheryl acetate, White petrolatum

Package Label

Antibiotic Ointment

Image Of Caton Label (Antibiotic.pro)

Image Of Caton Label (Antibiotic.pro)

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