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  5. Label Information: Betadine Dry Powder

FDA Label for Betadine Dry Powder

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. PURPOSE
    3. USES
    4. WARNINGS FOR EXTERNAL USE ONLY
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. ASK A DOCTOR BEFORE USE IF YOU HAVE
    8. STOP USE AND ASK A DOCTOR IF
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine Dry Powder Product Label

The following document was submitted to the FDA by the labeler of this product Atlantis Consumer Healthcare, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active ingredient

Povidone-iodine, 5% (0.5% available iodine).


Purpose



First aid antiseptic


Uses



First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Warnings For External Use Only



Extremely Flammable Do not use near heat, flame or while smoking. Do not puncture or incinerate. Contents under pressure. Do not store at temperatures above 120⁰F. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal


Do Not Use



  • in or near eyes
  • over large areas of the body
  • if you are allergic to povidone-iodine or any other ingredients in this preparation

When Using This Product



  • do not get into eyes. If contact occurs, rinse eyes thoroughly with water. If irritation persists, consult a doctor.

Ask A Doctor Before Use If You Have



  • deep or puncture wounds
  • serious burns
  • animal bites

Stop Use And Ask A Doctor If



  • the condition persists or gets worse
  • you need to use this product for more than 1 week

Directions



  • Clean the affected area
  • SHAKE WELL BEFORE USE
  • Hold can approximately 6 inches from wound and apply a thin layer over affected area 1 to 3 daily
  • May be covered with a sterile bandage

Other Information



  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive Ingredients



Isobutane, isopropyl myristate, pentrane, propane


Package Label.Principal Display Panel



Betadine Dry Powder Spray
NDC: 67618-165-01


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