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  5. Label Information: Povidone-iodine Scrub Swabstick

FDA Label for Povidone-iodine Scrub Swabstick

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT
    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
    18. CARTON INFORMATION

Povidone-iodine Scrub Swabstick 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 7.5% w/v (equivalent to 0.75% titratable iodine)


Purpose



Antiseptic


Uses



  • Health Care Antiseptic for preparation of the skin prior to surgery
    • First Aid 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
  • apply over large areas of the body
  • use on individuals who are allergic or sensitive to iodine
  • use as a first aid antiseptic for 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 condition persists for more than 72 hours
  • 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
  • clean the affected area
  • 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 15° - 30° C (59° - 86° F)

Inactive Ingredients



Citric acid, glycerin, purified water, sodium hydroxide, Surfonic N-95

Otc - Questions





Label Information



TRIADCat. No. 10-4401NDC 50730-4401-17.5% Povidone Iodine, USPPOVIDONE IODINESCRUB SWABSTICK (1's)Triad Disposables, Inc.Hartland, WI 53029 USAFor Hospital and Professional Use OnlyAntiseptic / GermicideContents:1 Swabstick

Carton Information



TRIADINE

Cat. No. 10-4401
NDC 50730-4401-1

Povidone Iodine, USP
POVIDONE IODINE
SCRUB SWABSTICK (1's)

Antiseptic / Germicide

Triad Disposables, Inc.
Brookfield, WI 53045

MADE IN USA

For Hospital and Professional Use
Store at Room Temperature

Contents:
50 Pouches
1 Swabstick per Pouch


carton - 10 4401C 050300

carton - 10 4401C 050300


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