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  5. Label Information: Loris Povidone-iodine Solution

FDA Label for Loris Povidone-iodine Solution

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTHER
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. QUESTIONS OR COMMENTS?
    11. PRINCIPAL DISPLAY PANEL

Loris Povidone-iodine Solution Product Label

The following document was submitted to the FDA by the labeler of this product Lernapharm Loris 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.

Active Ingredients



Povidone Iodine 10% w/v


Purpose



Antiseptic


Uses



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


Warnings



For External Use Only

Other



  • Do not use in the eyes.
  • Discontinue use if irritation and redness develop.

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.


Directions



  • Clean the area.
  • Apply product to the operative site prior to surgery.
  • Apply with friction for 30 seconds.
  • Do not blot or wipe away.

Other Information



Store at room temperature between 59-86oF (15-30oC). 1% titratable iodine. Latex free


Inactive Ingredients



Citric Acid, Glycerol, Nonoxynol-9, Purified Water, Sodium Hydroxide, Sodium Phosphate Dibasic


Questions Or Comments?



Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST


Principal Display Panel



Hold upright

Product # 119-XXU          NDC: 68356-119-XX

Loris Povidone-Iodine [Solution]

[TEAR OPEN]  [Tear here and pour]

Antiseptic

STERILE Solution

[Applicator is sterile] Unless package is opened or damaged

For hospital and professional use only

MANUFACTURED BY

LERNAPHARM (LORIS) INC.

2323 HALPERN, VILLE ST-LAURENT

QUEBEC, CANADA H4S 1S3


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