1. Home
  2. Labeler Index
  3. Atlantis Consumer Healthcare, Inc.
  4. 67618-160
  5. Label Information: Betadine

FDA Label for Betadine

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. OTC - DO NOT USE
    5. OTC - STOP USE
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. OTC - WHEN USING
    8. HOW SUPPLIED
    9. INACTIVE INGREDIENT
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Betadine 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.

Otc - Active Ingredient



Active ingredient

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


Otc - Purpose



Purpose

First aid antiseptic


Indications & Usage



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 povidone-iodine or any other ingredients in this preparation

Otc - Do Not Use



    Ask a doctor before use if you have
  • deep or puncture wounds
  • serious burns
  • animal bites

Otc - Stop Use



    Stop use and ask a doctor if
  • the condition persists or gets worse
  • you need to use this product for more than 1 week

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.


Otc - When Using



Directions

  • clean the affected area
  • spray a small amount of this product on the area 1 to 3 times daily
  • if bandaged, let dry first

How Supplied



Other information

  • store at 25˚C (77˚F); excursions permitted between 15˚-30˚C (59˚-86˚F). Do not freeze.

Inactive Ingredient



Inactive ingredients

citric acid, dibasic sodium phosphate, glycerin, nonoxynol-9, purified water

Dist. by:
Purdue Products L.P.
Stamford, CT 06901-3431

303814-0B

©2015, Purdue Products L.P.



Package Label.Principal Display Panel



Betadine Spray
NDC: 67618-160-03


* Please review the disclaimer below.