FDA Label for Betadine Solution

View Indications, Usage & Precautions

Betadine Solution 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, 10% (1% available iodine)


Purpose



First aid antiseptic


Uses



First aid to help prevent infection in minor

  • cuts
  • scrapes
  • burns

Do Not Use



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

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
  • apply a small amount of product to the area 1 to 3 times daily
  • may be covered with a sterile bandage
  • if bandaged, let dry first

Other Information



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

Inactive Ingredients



citric acid, disodium phosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide


Package Label.Principal Display Panel



Betadine Solution 8 fl oz Bottle
NDC: 67618-150-08


* Please review the disclaimer below.