Atopalm First Aid Triple Antibiotic Protection Moisturizing And Pain Relief
FDA Label NDC 51141-0238

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 Atopalm First Aid Triple Antibiotic Protection Moisturizing And Pain Relief (NDC 51141-0238). 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 (each gram contains), purpose, uses, warnings, do not use, ask a doctor before use, 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 (Each Gram Contains)

Bacitracin Zinc 500 units

Neomycin Sulfate 3.5mg

Polymycin B Sulfate 10,000 units

Pramoxine HCl 10mg

Purpose



First Aid Antibiotic
Topical Analgesic

Uses

First aid to help prevent infection and for the temporary relief of pain and discomfort of minor cuts, scrapes, burns.

Warnings

For external use only

Do Not Use

  • if you are allergic to any of the ingredients
  • in or near the eyes
  • longer than 1 week
  • over large areas of the body

Ask A Doctor Before Use

  • on deep or puncture wounds, animal bites or serious burns

Stop Use And Ask A Doctor If

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days
  • a rash or other allergic reaction develops.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and older

  • clean the affected area and dry throughly
  • apply a small 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 yrs. of age

    • Consult a doctor.

Other Information

  • store at 68° – 77°F (20° – 25°C)
  • see carton flap or tube crimp for lot number and expiration date

Inactive Ingredients

PETROLATUM, LIGHT MINERAL OIL, STEARIC ACID, CHOLESTEROL, MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHMIDE MEA.

Questions Or Information Call Toll Free:

Call 1-855-ATOPALM

Package Label.Principal Display Panel


Atopalmmoisturizingfirstaidtripleantibioticprotection (Atopalmmoisturizingfirstaidtripleantibioticprotection)

Atopalmmoisturizingfirstaidtripleantibioticprotection (Atopalmmoisturizingfirstaidtripleantibioticprotection)

Atopalmmoisturizingfirstaidtripleantibioticprotectioninner (Atopalmmoisturizingfirstaidtripleantibioticprotectioninner)

Atopalmmoisturizingfirstaidtripleantibioticprotectioninner (Atopalmmoisturizingfirstaidtripleantibioticprotectioninner)

* Please review the disclaimer below.