Povidone Iodine Prep Pad

Povidone Iodine Prep Pad
SPL v5
SPL
SPL Set ID 47a504b8-b0c0-030a-e054-00144ff88e88
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 Glycerin Nonoxynol-10 Water Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2017-01-30 Until 2017-01-30

Description

Povidone lodine USP,10% w/v (equivalent to 1% titratable iodine)


Medication Information

Description

Povidone lodine USP,10% w/v (equivalent to 1% titratable iodine)

Use

First aid to help prevent infection in minor cuts,scrqpes,and burns

Do Not
  • use in the eyes 
  • apply over large areas of the body. 
  • use on individuals who are allergic or sensitive to iodine.
Section 55105-1

First Aid Antiseptic

Warnings

For external use only.

Directions
  • Clean the affected area 
  • Apply product on the area 1-3 times daily and discard 
  • May be covered with a sterile bandage when dry
Ask A Doctor

in case of deep or puncture wounds, animal bites,serious burns.

Active Ingredient

Povidone lodine USP,10% w/v (equivalent to 1% titratable iodine)

Other Information
  • Avoid excessive heat 
  • store at room temperature: 15°-30°C(59°-86°F)
Package Labeling:

Inactive Ingredients

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

Stop Use and Consult A Doctor
  • if the condition persists or gets worse 
  • for use longer than 1 week.
Keep out of Reach of Children.

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


Structured Label Content

Use

First aid to help prevent infection in minor cuts,scrqpes,and burns

Do Not (Do not)
  • use in the eyes 
  • apply over large areas of the body. 
  • use on individuals who are allergic or sensitive to iodine.
Section 55105-1 (55105-1)

First Aid Antiseptic

Warnings

For external use only.

Directions
  • Clean the affected area 
  • Apply product on the area 1-3 times daily and discard 
  • May be covered with a sterile bandage when dry
Ask A Doctor (Ask a doctor)

in case of deep or puncture wounds, animal bites,serious burns.

Active Ingredient (Active ingredient)

Povidone lodine USP,10% w/v (equivalent to 1% titratable iodine)

Other Information (Other information)
  • Avoid excessive heat 
  • store at room temperature: 15°-30°C(59°-86°F)
Package Labeling:

Inactive Ingredients (Inactive ingredients)

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

Stop Use and Consult A Doctor (Stop use and consult a doctor)
  • if the condition persists or gets worse 
  • for use longer than 1 week.
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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