FDA Label for Full Care Povidone Iodine Solution

View Indications, Usage & Precautions

Full Care Povidone Iodine Solution Product Label

The following document was submitted to the FDA by the labeler of this product Shaoxing Fuqing Health Products Co., Ltd.. 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 USP 10% (1.0% Available Iodine)


Otc - Purpose



Purpose: Antiseptic


Indications & Usage



Use: Prepping Intact Skin and Mucous Membranes Prior to Surgery


Warnings



Warnings:

For external use only

Avoid use on persons allergic to iodine


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or consult a poison control center right away


Otc - Ask Doctor



Stop use and ask a doctor if

  • Skin shows symptoms of irritation, sensitivity, redness, pain, or swelling.

Dosage & Administration



Directions: Patient Preoperative Prep:

Use full strength. Apply solution to preoperative site following povidone iodine scrub application. Use a circular motion,start as incision site and move onward. Remove all soiled underdrapes. Do not allow solution to pool.


Other Safety Information



Other information

  • Store at room temperature.
  • Avoid excessive heat (above 104F/40C)
  • Protect from freezing)
  • Laetx free

Inactive Ingredient



Inactive Ingredient

Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water


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