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  5. Label Information: Triadine Whirlpool

FDA Label for Triadine Whirlpool

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
    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. LABEL INFORMATION

Triadine Whirlpool 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,10% (Equivalent to 1% titratable iodine)


Purpose



Antiseptic


Uses



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

Warnings



For external use only.



Do Not Use



  • in the eyes
  • use as a first aid antiseptic for longer than one week
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body

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 condition persists or gets worse
  • if irritation and redness develop and persist for over 72 hours.

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 room temperature 20° - 25° C (68° - 77° F)

Inactive Ingredients



Citric acid, glycerin, nonoxynol-9, sodium hydroxide, water

Otc - Questions





Label Information



Triad

Cat. No. 10-8428
NDC 50730-8428-6


TRIADINE
POVIDONE-IODINE, USP
WHIRLPOOL CONCENTRATE
10% Solution

Antiseptic / Germicide

For general antiseptic use in Whirlpool or other hydrotherapy tanks.

For External Use Only!


128 Fluid Ounces (3.785 L)


label - 10 8428L B0909

label - 10 8428L B0909





* Please review the disclaimer below.