FDA Label for Good Care Povidone Iodine Swabsticks

View Indications, Usage & Precautions

Good Care Povidone Iodine Swabsticks Product Label

The following document was submitted to the FDA by the labeler of this product Dalian Goodwood Medical Care 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.

Good Care Povidone Iodine, Usp Swabsticks





Active Ingredient



Povidone Iodine USP, 10%


Purpose



Antiseptic


Uses



  • Health-care antiseptic for preparation of the skin prior to surgery
  • First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns

Warnings



  • For external use only. Do not use or apply in the eyes
  • on individuals who are allergic or sensitive to iodine
  • over large areas of the body
  • as a first aid antiseptic longer than 1 week unless directed by a doctor

Otc - Stop Use



Discontinue use if irritation and redness develop.Consult a doctor in case of deep or puncture wounds, animal bites, serious burns.Stop use and consult a doctor if the condition persists or gets worse.

Otc - Keep Out Of Reach Of Children



Keep out of reach of children.

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

Directions



For preparation of the skin prior to surgery clean the affected area, remove swab by stick, apply to the operative site prior to surgeryFor use as a first aid antiseptic clean the affected area, apply a small amount of this product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Other Information



  • Store at room temperature: 15 degrees - 30 degrees C (59 degrees - 86 degrees F)

Inactive Ingredients



Purified water, Povidone Iodine, Citric Acid Disodium Hydrogen Phosphate Dodecahydrate Potassium Iodate Nonoxynol


Manufactured By Dalian Goodwood Medical Care Ltd.



Made in China


Good Care Povidone Iodine, Usp Swabsticks (1S) (50 Pouches/Box) (50685-009-01)





Good Care Povidone Iodine, Usp Swabsticks (2S) (25 Pouches/Box) (50685-009-02)





Good Care Povidone Iodine, Usp Swabsticks (3S) (25 Pouches/Box) (50685-009-03)





* Please review the disclaimer below.