Povidone Iodine Prep Swabstick

Povidone Iodine Prep Swabstick
SPL v4
SPL
SPL Set ID 47a5726f-d314-50d9-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2017-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-30

Description

Povidone lodine USP, 10% W/V (equivalent to 0.75% titratable iodine)

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone lodine USP, 10% W/V (equivalent to 0.75% 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 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.
Active Ingredient

Povidone lodine USP, 10% W/V (equivalent to 0.75% titratable iodine)

Other Information

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

  • Avoid excessive heat
Package Labeling:

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 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.
Active Ingredient (Active ingredient)

Povidone lodine USP, 10% W/V (equivalent to 0.75% titratable iodine)

Other Information (Other information)

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

  • Avoid excessive heat
Package Labeling:

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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