1. Home
  2. Labeler Index
  3. Dalian Goodwood Medical Care Ltd.
  4. 50685-001
  5. Label Information: Good Care Povidone Iodine

FDA Label for Good Care Povidone Iodine

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. STORAGE AND HANDLING
    10. INACTIVE INGREDIENT
    11. OTHER
    12. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Good Care Povidone Iodine 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.

Otc - Active Ingredient



Active Ingredient

Povidone Iodine USP, 10% w/v

(equivalent to 1% titratable iodine)


Otc - Purpose



Purpose

Antiseptic


Indications & Usage



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



Warnings

For external use only.


Otc - Do Not Use



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
    • Discontinue use if irritation and redness develop.

Otc - Stop Use



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 Center right away.


Dosage & Administration



Directions

For preparation of the skin prior to surgery clean the affected area, remove swab by the stick, apply to the operative site prior to surgery.

For 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.


Storage And Handling



Other information

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


Inactive Ingredient



Inactive ingredients

citric acid, glycerin, nonoxynol-8, purified water, sodium hydroxide


Other



Manufactured by DALIAN GOODWOOD MEDICAL CARE LTD.

3-91 Jiulicun Yongzheng Street Jinzhou District Dalian China 116100

Tel: +86-411-87857288

Made in China      www.dl-goodwood.com


Package Label.Principal Display Panel



Good Care

Povidone Iodine, USP Swabsticks

Antiseptic    Germicide

* Please review the disclaimer below.