OTC Medication Information: Dukal Povidone-Iodine Paint Sponge Stick

DUKAL POVIDONE-IODINE PAINT SPONGE STICK- povidone-iodine sponge
Dukal LLC

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, Hydroxyethyl Cellulose, Potassium Iodide, Purified Water, Sodium Hydroxide

Dukal™

Povidone-Iodine

Paint Sponge

Sticks

Sterile, Large

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 damaged or opened

2 Per Pouch Not Made with Natural Rubber Latex Do not re-use NDC-66517-0038-1 REF 909

909 Item
(click image for full-size original)

Dukal REF 909

Povidone-Iodine

Paint 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 65517-0038-1

909 Case
(click image for full-size original)
DUKAL POVIDONE-IODINE PAINT SPONGE STICK
povidone-iodine paint sponge stick sponge
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65517-0038
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
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65517-0038-1 2 APPLICATOR in 1 POUCH contains a APPLICATOR
1 72 mL in 1 APPLICATOR This package is contained within the POUCH (65517-0038-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M003 01/11/2023
Labeler — Dukal LLC (791014871)

Revised: 10/2023 Dukal LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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