4802 Povidone-iodine Scrub Nonsterile

4802 Povidone-iodine Scrub Nonsterile
SPL v14
SPL
SPL Set ID b8a23a29-2541-4987-a534-17a6369a6c8d
Route
TOPICAL
Published
Effective Date 2021-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Iodine (7.5 mg)
Inactive Ingredients
Sodium Phosphate, Dibasic Anhydrous Citric Acid Sodium Hydroxide Nonoxynol-9 Ammonium Nonoxynol-4 Sulfate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1998-01-01
Description

Povidone-iodine 7.5%

Purpose

Antiseptic

Medication Information

Purpose

Antiseptic

Description

Povidone-iodine 7.5%

Use
  • • antiseptic skin preparation
  • • single use when used for patient preoperative skin preparation
Warnings

  • For external use only
  • Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.
Directions

apply locally as needed

Do Not Use
  • • in the eyes
  • • on individuals allergic or sensitive to iodine
Package Label

Active Ingredient

Povidone-iodine 7.5%

Other Information
  • • 0.75% titratable iodine
  • • not made with natural rubber latex
  • • for hospital or professional use only
Inactive Ingredients

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Questions Or Comments?

1-800-633-5463

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Manufactured for:

Medline Inustries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

1-800-633-5463

RL17HND

REF: APL82364K

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

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

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

Structured Label Content

Use
  • • antiseptic skin preparation
  • • single use when used for patient preoperative skin preparation
Purpose

Antiseptic

Warnings

  • For external use only
  • Avoid "pooling" beneath patient. Prolonged exposure to wet solution may cause skin irritation.
Directions

apply locally as needed

Do Not Use (Do not use)
  • • in the eyes
  • • on individuals allergic or sensitive to iodine
Package Label

Active Ingredient

Povidone-iodine 7.5%

Other Information (Other information)
  • • 0.75% titratable iodine
  • • not made with natural rubber latex
  • • for hospital or professional use only
Inactive Ingredients (Inactive ingredients)

ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Questions Or Comments? (Questions or comments?)

1-800-633-5463

Manufacturing Information

Manufactured by:

Aplicare Products, LLC

550 Research Parkway, Meriden, CT 06450 USA

Manufactured for:

Medline Inustries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in USA with domestic and foreign materials

1-800-633-5463

RL17HND

REF: APL82364K

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • • infection occurs
  • • redness, irritation, swelling or pain persists or increases
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.

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:48.388677 · Updated: 2026-03-14T23:11:37.729091