Prep Solution Topical Antiseptic Microbicide

POVIDONE-IODINE TOPICAL HUMAN OTC DRUG

Prep Solution Topical Antiseptic Microbicide is an FDA drug label for the active ingredient POVIDONE-IODINE manufactured by Degasa SA De CV administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231105.

Generic name
POVIDONE-IODINE
Manufacturer
Degasa SA De CV
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
67326-350
Application
505G(a)(3)
Label effective
20231105

Active ingredients

Active Ingredient Povidone- Iodine, 10% (equivalent to 1% available Iodine). Purpose Antiseptic

Indications & Usage

Uses Healthcare antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent infection in minor cuts, scrapes and burns.

Dosage & Administration

Directions For preparation of the skin prior to surgery: Skin preparation for the skin: 1.Clean the area, 2. Apply product to the operative site prior to surgery. For first aid antiseptic 1. Clean the affected area, 2. Apply a small amount of the product on the area 1-3 times daily, 3. May be covered with a sterile bandage, 4. If bandaged, let dry first.

Contraindications

Not available.

Warnings

Warnings: For external use only Do not use: In the eyes, on deep or puncture wounds, on individuals who are allergic or sensitive to iodine, as a first aid antiseptic longer than one week and in serious burns. Stop use and ask a doctor if Irritation and redness develop and if conditions persist for more than 72 hours. Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Adverse Reactions

Not available.

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