Povidone Iodine Scrub Swabstick 3's

Povidone Iodine Scrub Swabstick 3's
SPL v2
SPL
SPL Set ID 65783da9-acca-41c7-860b-1de108edc583
Route
TOPICAL
Published
Effective Date 2022-10-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Hydroxyethyl Cellulose, Unspecified Nonoxynol-10 Glycerin Sodium Hydroxide Potassium Iodide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-11-19

Description

Povidone Iodine USP, 10% W/W (equivalent to 1% titratable iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone Iodine USP, 10% W/W (equivalent to 1% titratable iodine)

Use
  • 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.
Do Not
  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body
  • use as a first aid antiseptic longer than 1 week unless directed by a doctor. if irritation and redness develop. Discontinue use
Warnings

For external use only.

Directions

For preparation of the skin prior to surgery

For use as a first aid antiseptic

  • clean the affected area
  • remove swab by stick
  • apply to the operative site prior to surgery.
  • clean the affected area
  • apply a small amount of this product on the area
  • may be covered with a sterile bandage
  • if benadaged, let dry first.
Drug Facts

Active Ingredient

Povidone Iodine USP, 10% W/W (equivalent to 1% titratable iodine)

Other Information

Avoid excessive heat. Store at room temperature.

Package Labeling:

Inactive Ingredients

Citric acid, alkyl glucoside, hydroxyethyl cellulose, nonoxynol-10, glycerin, sodium hydroxide, potassium iodide, purified water

Consult A Doctor in Case Of
  • deep or puncture wounds
  • animals bites
  • serious burns. 
Stop Use and Consult A Doctor
  • if the condition persists or gets worse
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use
  • 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.
Do Not (Do not)
  • use in the eyes
  • use on individuals who are allergic or sensitive to iodine
  • apply over large areas of the body
  • use as a first aid antiseptic longer than 1 week unless directed by a doctor. if irritation and redness develop. Discontinue use
Purpose

Antiseptic

Warnings

For external use only.

Directions

For preparation of the skin prior to surgery

For use as a first aid antiseptic

  • clean the affected area
  • remove swab by stick
  • apply to the operative site prior to surgery.
  • clean the affected area
  • apply a small amount of this product on the area
  • may be covered with a sterile bandage
  • if benadaged, let dry first.
Drug Facts

Active Ingredient (Active ingredient)

Povidone Iodine USP, 10% W/W (equivalent to 1% titratable iodine)

Other Information (Other information)

Avoid excessive heat. Store at room temperature.

Package Labeling:

Inactive Ingredients (Inactive ingredients)

Citric acid, alkyl glucoside, hydroxyethyl cellulose, nonoxynol-10, glycerin, sodium hydroxide, potassium iodide, purified water

Consult A Doctor in Case Of (Consult a doctor in case of)
  • deep or puncture wounds
  • animals bites
  • serious burns. 
Stop Use and Consult A Doctor (Stop use and consult a doctor)
  • if the condition persists or gets worse
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.


Advanced Ingredient Data


Raw Label Data

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