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  5. Label Information: Povidone Iodine Plus

FDA Label for Povidone Iodine Plus

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. ASK A DOCTOR IN CASE OF
    7. OTC - ASK DOCTOR/PHARMACIST
    8. OTC - WHEN USING
    9. STOP USE AND ASK A DOCTOR IF
    10. OTC - PREGNANCY OR BREAST FEEDING
    11. KEEP OUT OF REACH OF CHILDREN
    12. DIRECTIONS
    13. OTHER
    14. OTHER INFORMATION
    15. INACTIVE INGREDIENTS
    16. OTC - QUESTIONS
    17. PACKAGE INFORMATION

Povidone Iodine Plus Product Label

The following document was submitted to the FDA by the labeler of this product H And P Industries, Inc. Dba Triad Group. 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% (equivalent to 1% titratable iodine)


Purpose



Antiseptic


Uses



  • Health care 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
  • on individuals who are allergic or sensitive to iodine
  • as a first aid antiseptic longer than 1 week unless directed by a doctor

Ask A Doctor In Case Of



  • deep or puncture wounds
  • animal bites
  • serious burns

Otc - Ask Doctor/Pharmacist





Otc - When Using





Stop Use And Ask A Doctor If



  • irritation and redness develop

Otc - Pregnancy Or Breast Feeding





Keep Out Of Reach Of Children



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


Directions



For preparation of the skin prior to surgery
  • apply to the operative site prior to surgery
    • As a first aid antiseptic
    • clean the affected area
    • apply a small amount of this product to the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first

Other





Other Information



Store at 15° - 30° C (59° - 86° F)

Inactive Ingredients



Citric acid, glycerin, hydroxyethylcellulose, sodium hydroxide, water

Otc - Questions





Package Information



Cat. No. 11-LP14
NDC 50730-8214-8

TRIAD Plus

POVIDONE IODINE
PREP GEL

Povidone Iodine, USP
10% Topical Gel

  • ANTISEPTIC for preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.
  • For Hospital and Professional use.
    • 4 Fluid Ounces (118 ml)

    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029    Made In USA
    www.triad-group.net

    label - 11 LP14L B0210

    label - 11 LP14L B0210






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