povidone-iodine solution, non-sterile

povidone-iodine solution, non-sterile
SPL v6
SPL
SPL Set ID 2d1b3833-bacc-493e-99c9-40825bff3327
Route
topical
Published
Effective Date 2023-11-16
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 drug active Since 2018-06-29

Purpose

Antiseptic

Description

Povidone-lodine 10%w/w


Medication Information

Purpose

Antiseptic

Other Information
  • 1% titratable iodine
  • for hospital or professional use only
Description

Povidone-lodine 10%w/w

Use

for antiseptic skin preparation

Driections

apply locally as needed

Drug Facts

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

Povidone-lodine 10%w/w

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

Purpose

Antiseptic

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

for antiseptic skin preparation

Driections

apply locally as needed

Drug Facts

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

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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