Antibiotic Ointment
FDA Label NDC 51141-0066

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Neopharm Co., Ltd. for the product Antibiotic Ointment (NDC 51141-0066). 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 Sulfate 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 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 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

Liquid paraffin, Cethanol, Squalane, Purified lanolin, White petrolatum, Cetearyl alcohol, Tocopheryl acetate,

Methylparaben, Propylparaben

Package Label

Antibiotic Ointment

Image Of Caton Label (Antibiotic.carton)

Image Of Caton Label (Antibiotic.carton)

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