Povidone Iodine Prep

Povidone Iodine Prep
SPL v10
SPL
SPL Set ID 1e5aed0c-bd51-4ac8-9877-71bf18050dfd
Route
TOPICAL
Published
Effective Date 2013-06-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Water Glycerin Sodium Citrate Polysorbate 80 Sodium Phosphate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2011-12-21

Description

Active Ingredient                                  Purpose Povidone Iodine 10% v/v                        Antiseptic                          


Medication Information

Indications and Usage

For use as an

  • first aid antiseptic

  • pre-operative skin preperation

Description

Active Ingredient                                  Purpose Povidone Iodine 10% v/v                        Antiseptic                          

Uses


  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
  • Healthcare antiseptic for preparation of the skin prior to surgery.
  • Antiseptic cleanser for preparation of skin prior to an infection.
Stop Use
  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.
Warnings
  • FOR EXTERNAL USE ONLY
Directions

As a first aid antiseptic

  • clean affected area
  • apply a small amount of this product to the area1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged let dry.


For preoperative patient skin preparation



  • clean area
  • apply to operative site prior to surgery using the applicator
Do Not Use


  • As a first aid antiseptic for more than 1 week unless directed by a doctor.
  • In the eyes.
  • Over large areas of the body.
  • On individuals who are allergic  or sensitive to iodine.
Active Ingredient

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Inactive Ingredient
  • citric acid
  • glycerin
  • sodium citrate
  • tween 80
  • disodium phosphate
  • purified Water
Principal Display Panel

Keep Out of Reach of Children

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.



Ask A Doctor Before Use If You Have
  • Deep puncture wounds
  • Animal bites
  • Serious burns

Structured Label Content

Uses


  • First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.
  • Healthcare antiseptic for preparation of the skin prior to surgery.
  • Antiseptic cleanser for preparation of skin prior to an infection.
Indications and Usage (34067-9)

For use as an

  • first aid antiseptic

  • pre-operative skin preperation

Stop Use
  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.
Warnings
  • FOR EXTERNAL USE ONLY
Directions

As a first aid antiseptic

  • clean affected area
  • apply a small amount of this product to the area1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged let dry.


For preoperative patient skin preparation



  • clean area
  • apply to operative site prior to surgery using the applicator
Do Not Use (Do not use)


  • As a first aid antiseptic for more than 1 week unless directed by a doctor.
  • In the eyes.
  • Over large areas of the body.
  • On individuals who are allergic  or sensitive to iodine.
Active Ingredient (Active ingredient)

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Inactive Ingredient
  • citric acid
  • glycerin
  • sodium citrate
  • tween 80
  • disodium phosphate
  • purified Water
Principal Display Panel

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center.



Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • Deep puncture wounds
  • Animal bites
  • Serious burns

Advanced Ingredient Data


Raw Label Data

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