Polvos De Sulpha Powder
FDA Label NDC 53145-304

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Menper Distributors Inc. for the product Polvos De Sulpha (NDC 53145-304). 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, purpose, uses, warnings, ask a doctor before use if you have, stop use and ask a doctor if, keep out of reach of childrens, directionsadults and children 2 years of age and older, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active ingredients (each gram contains) Purpose

Bacitracin zinc 500 units.....................................................................................First aid

Polymyxin B sulfate 10,000 units.........................................................................First aid antibiotic

Purpose

First aid

First aid antibiotic

Uses

first aid to help prevent infection in minor 

  • cuts
  • scrapes
  • burns

Warnings

For fexternal use only

Ask A Doctor Before Use If You Have

deep or puncture wounds, animal bites, or serious burns

Stop Use And Ask A Doctor If

The condition persists or gets worsen 

a rash or other alergic reaction develops

Keep Out Of Reach Of Childrens

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

Directionsadults And Children 2 Years Of Age And Older

  • clean the affected area 
  • apply a light dusting of the powder on the area 1 to 3 times daily 
  • may be covered with a sterile bandages children under 2 years of age: consult a doctor

Other Information

  • store at 15° to 25° C (59° to 86° F)
  • do not refrigerate

    • Tamper-Evident: Do not use if there is evidence of tampering 

Inactive Ingredients

Lactose 

Questions?

1-800-560-5223 M-F 9 AM to 5 PM Eastern Time 

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