FDA Label for Zonsen Povidone-iodine Prep Pad

View Indications, Usage & Precautions

Zonsen Povidone-iodine Prep Pad Product Label

The following document was submitted to the FDA by the labeler of this product Wuhan Zonsen 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 Ingredients



Povidone-Iodine 10% w/w (1% available iodine)


Purpose



Antiseptic


Use



  • Healthcare antiseptic for preparation of the skin prior to surgery.
  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Warnings



  • For external use only.

Do Not Use



  • in the eyes.
  • longer than 1 week unless directed by a doctor.
  • on individuals who are allergic or sensitive to iodine.
  • or apply over large areas of the body.

Stop Use And Ask A Doctor If



  • If irritation and redness develop.
  • condition persist for more than 72 hours.
  • In case of deep or puncture wounds, animal bites or serious burns, consult a doctor.

Keep Out Of Reach Of Children.



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


Directions



  • Clean the affected area.
  • For preparation of the skin prior to surgery: apply product to the operative site prior to surgery 
  • For first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Inactive Ingredients:



Sodium hydroxide, water


Other Information



  • Protect from freezing
  • Avoid excessive heat.

Package Labeling:




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