Povidone Iodine Prep Swabstick

Povidone Iodine Prep Swabstick
SPL v1
SPL
SPL Set ID c1862529-e8d8-4440-a043-38c01079ee8a
Route
TOPICAL
Published
Effective Date 2024-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (100 mg)
Inactive Ingredients
Citric Acid Monohydrate Water Sodium Hydroxide Nonoxynol-10 Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-01

Description

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

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone Iodine USP, 10% W/V (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. Discontinue use if irritation and irritation and redness develop. Consult a doctor in case of
  • deep or puncture wounds
  • animal bites
  • serious burns.
Warnings

For external use only.

Directions

For preparation of the skin prior to surgery

  • clean the affected area remove swab by 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.
Drug Facts

34645 5506 0

34645 5506 1

Active Ingredient

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

Other Information

store at room temperature: 15°—30°C(59°-86°F)

  • Avoid excessive heat
Inactive Ingredients

citric acid, purified water, sodium hydroxide, Nonoxynol - 10, glycerin

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. Discontinue use if irritation and irritation and redness develop. Consult a doctor in case of
  • deep or puncture wounds
  • animal bites
  • serious burns.
Purpose

Antiseptic

Warnings

For external use only.

Directions

For preparation of the skin prior to surgery

  • clean the affected area remove swab by 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.
Drug Facts

34645 5506 0 (34645-5506-0)

34645 5506 1 (34645-5506-1)

Active Ingredient (Active ingredient)

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

Other Information (Other information)

store at room temperature: 15°—30°C(59°-86°F)

  • Avoid excessive heat
Inactive Ingredients (Inactive ingredients)

citric acid, purified water, sodium hydroxide, Nonoxynol - 10, glycerin

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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