sunmark Povidone-Iodine Topical

sunmark Povidone-Iodine Topical is an FDA drug label for the active ingredient POVIDONE-IODINE manufactured by Strategic Sourcing Services LLC 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 20231219.

Generic: POVIDONE-IODINE

Manufacturer: Strategic Sourcing Services LLC

Product Type: HUMAN OTC DRUG

Route: TOPICAL

Dosage Form:

NDC: 49348-622

Application: M003

Effective: 20231219

Active Ingredients: Active Ingredient Povidone Iodine 10% (*Equivalent to 1% titratable Iodine)

Indications & Usage

Uses First aid antiseptic to prevent infection in minor cuts, burns.

Dosage & Administration

Directions Clean the affected area Apply a small amount on the area 1 to 3 times daily. May be covered with a sterile bandage. If bandaged, let dry first.

Contraindications

Not available.

Warnings

Warnings For external use only. Do not: use in the eyes. use longer than 1 week unless directed by a doctor. use on individuals who are allergic or sensitive to iodine. apply over large areas of the body. Stop use and consult a doctor if condition persists or gets worse. irritation and redness develop and persist for more than 72 hours. Ask a doctor in case of: deep or puncture wounds animal bites serious burns. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Adverse Reactions

Not available.

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