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Aplicare Povidone Iodine Scrub

Package insert / prescribing information
Generic name: povidone-iodine
Dosage form: topical solution
Drug classes: Antiseptic and germicides, Vaginal anti-infectives

Medically reviewed by Drugs.com. Last updated on Dec 1, 2021.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Povidone-iodine 7.5%

Purpose

Antiseptic

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.

Do not use

  • • in the eyes
  • • on individuals allergic or sensitive to iodine

Ask a doctor before use if injuries are

  • • deep or puncture wounds
  • • serious burns

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.

Directions

apply locally as needed

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

Package Label

APLICARE POVIDONE-IODINE SCRUB
povidone-iodine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-4802
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (IODINE) IODINE 7.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC
ANHYDROUS CITRIC ACID
SODIUM HYDROXIDE
NONOXYNOL-9
AMMONIUM NONOXYNOL-4 SULFATE
WATER
Packaging
# Item Code Package Description
1 NDC:52380-4802-8 118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/01/1998
Labeler - Aplicare Products, LLC (081054904)
Registrant - Medline Industries, LP (025460908)
Aplicare Products, LLC