povidone iodine scrub swabstick

povidone iodine scrub swabstick
SPL v5
SPL
SPL Set ID 47a5690c-08ad-5092-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 (7.5 g)
Inactive Ingredients
citric acid monohydrate water sodium hydroxide nonoxynol-10 glycerin

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2017-01-30

Purpose

Antiseptic

Description

Povidone lodine USP,7.5% W/V (equivalent to 0.75% titratable iodine)


Medication Information

Warnings

For external use only.

Purpose

Antiseptic

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.
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

Description

Povidone lodine USP,7.5% 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.
Active Ingredient

Povidone lodine USP,7.5% W/V (equivalent to 0.75% titratable iodine)

Package Labeling:

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

Warnings

For external use only.

Purpose

Antiseptic

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.
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

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.
Active Ingredient (Active ingredient)

Povidone lodine USP,7.5% W/V (equivalent to 0.75% titratable iodine)

Package Labeling:

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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