Povidone-iodine Solution, Non-sterile

Povidone-iodine Solution, Non-sterile
SPL v1
SPL
SPL Set ID 123e147b-ad97-4f46-8291-cebda20a712f
Route
TOPICAL
Published
Effective Date 2018-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-06-29

Description

Povidone-lodine 10%w/w

Purpose

Antiseptic


Medication Information

Purpose

Antiseptic

Description

Povidone-lodine 10%w/w

Use

for antiseptic skin preparation

Driections

apply locally as needed

Do Not Use
  • if allergic to lodine
  • do not use in the eye
Active Ingredient

Povidone-lodine 10%w/w

Other Information
  • 1% titratable iodine
  • for hospital or professional use only
Package Labeling:

Inactive Ingredients:

Citrc Acid, Alkyl Glucoside, Hydroxyethy, Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium lodide, Purifed Water.

Stop Use and Ask A Doctor If
  • redness, irritation, swelling or pain persists or increases
  • infection occurs
Keep Out of Reach of Children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Avoid pooling beneath patient.

Ask A Doctor Before Use If Injuries Are
  • deep or puncture wounds
  • serious burns

Structured Label Content

Use

for antiseptic skin preparation

Purpose

Antiseptic

Driections

apply locally as needed

Do Not Use (do not use)
  • if allergic to lodine
  • do not use in the eye
Active Ingredient (Active ingredient)

Povidone-lodine 10%w/w

Other Information (Other information)
  • 1% titratable iodine
  • for hospital or professional use only
Package Labeling:

Inactive Ingredients: (Inactive ingredients:)

Citrc Acid, Alkyl Glucoside, Hydroxyethy, Cellulose, Nonoxynol-10, Glycerin, Sodium Hydroxide, Potassium lodide, Purifed Water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • redness, irritation, swelling or pain persists or increases
  • infection occurs
Keep Out of Reach of Children. (Keep out of reach of children.)

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

Avoid pooling beneath patient.

Ask A Doctor Before Use If Injuries Are (Ask a doctor before use if injuries are)
  • deep or puncture wounds
  • serious burns

Advanced Ingredient Data


Raw Label Data

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