Povidone Iodine Gel Swabstick

Povidone Iodine Gel Swabstick
SPL v1
SPL
SPL Set ID 9262e033-8f8c-4d41-88f1-19a4da30d9db
Route
TOPICAL
Published
Effective Date 2012-02-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Povidone-iodine (10 mL)
Inactive Ingredients
Nonoxynol-10 Citric Acid Monohydrate Water Glycerin Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-02-10

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 skin infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infections.

Section 55106-9

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Stop Use:



  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Warnings:



  • FOR EXTERNAL USE ONLY

Do Not Use:


  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Other Information:

Sterile

Store at room temperature.

Avoid excessive heat

Inactive Ingredients

Inactive ingredients: citric acid, glycerol, nonoxynol-10, sodium hydroxide, water

Principal Display Panel




PVP_Gel_Swabstick

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

Directions Povidone Iodine Gel Swabstick:

Tear at notch, remove applicator, use only once.

As a first aid antiseptic

  • clean affected area
  • apply 1 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




Structured Label Content

Uses:






  • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infections.

Indications and Usage (34067-9)

For use as an

  • first aid antiseptic

  • pre-operative skin preperation

Section 55106-9 (55106-9)

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Stop Use:



  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Warnings:



  • FOR EXTERNAL USE ONLY

Do Not Use: (Do not use:)


  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Other Information: (Other information:)

Sterile

Store at room temperature.

Avoid excessive heat

Inactive Ingredients

Inactive ingredients: citric acid, glycerol, nonoxynol-10, sodium hydroxide, water

Principal Display Panel




PVP_Gel_Swabstick

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

Directions Povidone Iodine Gel Swabstick:

Tear at notch, remove applicator, use only once.

As a first aid antiseptic

  • clean affected area
  • apply 1 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




Advanced Ingredient Data


Raw Label Data

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