FDA Label for Povidone-iodine Prep Sterile

View Indications, Usage & Precautions

Povidone-iodine Prep Sterile Product Label

The following document was submitted to the FDA by the labeler of this product Changzhou Maokang Medical 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.

Active Ingredient



Povidone-Iodine USP 10%


Purpose



Antiseptic


Use



  • For preparation prior to surgery 
  • Helps to reduce bacteria that can potentially cause skin infection.

Warnings



For external use only.

Do not apply to persons allergic to iodine


Do Not Use



  • in the eyes

Ask A Doctor Before Use If



injuries are • deep wounds

• puncture wounds • serious burns


Stop Use And Ask A Doctor If



• irritation and redness develop 

• condition persists for more than 72 hours • infection occurs

Avoid pooling beneath the patient.Prolonged exposure to wet solution may cause skin irritation.


Keep Out Of Reach Of Children.



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


Directions



Clean the area. Apply product to the operative site prior to surgery using sponge sticks to prep desired area.


Other Information



• 1% titratable iodine • latex free • for hospital or professional use only


Inactive Ingredients



Citric Acid, Alkyl Glucoside, Hydroxyethyl Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium Iodide, Purified Water


Package Labeling:




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