OTC Medication Information: Dukal Povidone-Iodine Scrub Sponge Sticks

DUKAL POVIDONE-IODINE SCRUB SPONGE STICKS- povidone-iodine sponge
Dukal LLC

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 USP 10%

Purpose

Antiseptic

Use

Patient preoperative skin preparation. Helps to reduc bacteria that potentially can cause skin infection.

Warnings:

For external use only.

• Do not apply to persons allergic to iodine. Do not use in the eyes.

• Ask a doctor before use if injuries are deep wounds, puncture wounds, serious burns.

Stop use and ask doctor if infection occurs, redness, irritation or swelling develops.

• Keep out of reach of children
• If swallowed or gets in eyes, get medical help or contact Poison Control Center right away.

Directions

Apply product to skin as needed.

Other Information:

1% titratable iodine, Avoid excessive heat, Store at room temperature, For hospital or professional use only, Not made with natural rubber latex

Inactive Ingredients:

Alkyl Glucoside, Anhydrous Citric Acid, Glycerin, Nonoxynol-10, Potassium Iodide, Purified Water, Sodium Hydroxide, Sodium Lauryl Sulfate

Povidone-Iodine

Scrub Sponge

Sticks

Sterile

Antispetic

Drug Facts

Active ingredient Purpose

Povidone Iodine USP 10% Antiseptic

Use Patient preoperative skin preparation. Helps to reduce bacteria

that potentially can cause skin infection.

Warnings

For external use only.

Do no use if allergic to iodine, in the eyes

Sterile unless package is damagedor opened

2 Per Pouch Not Made with Natural Rubber Latex Do not re-use NDC-66517-0040-1 REF 911

Dukal REF 911

Povidone-Iodine

Scrub Scrub Sponge Sticks

Sterile
Antiseptic

For Professional and Hospital Use

8 Boxes Per Case

10 Pouches Per Pack

2 Per Pouch

Not Made with Natural Rubber Latex Do not re-use NDC 65517-0040-1

DUKAL POVIDONE-IODINE SCRUB SPONGE STICKS povidone-iodine scrub sponge sticks sponge

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65517-0040 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (IODINE) IODINE 1.1 g in 100 mL

Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID POTASSIUM IODIDE GLYCERIN NONOXYNOL-10 WATER C12-20 ALKYL GLUCOSIDE SODIUM LAURYL SULFATE SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:65517-0040-1 2 APPLICATOR in 1 POUCH contains a APPLICATOR 1 72 mL in 1 APPLICATOR This package is contained within the POUCH (65517-0040-1)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 03/15/2023

Labeler — Dukal LLC (791014871)

Revised: 03/2023 Dukal LLC