Drugplain

Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub 75 mg/mL

POVIDONE-IODINE · SOLUTION · Degasa SA De CV

No Recall History
Plain English

Povidone-iodine is an antiseptic solution used to clean and disinfect skin before surgery and medical procedures, as well as for surgical hand scrubbing. It is available over-the-counter as a topical preparation applied directly to the skin.

Key Facts

Brand Name
Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub
Generic Name
POVIDONE-IODINE
NDC Code (Product)
67326-352
Manufacturer
Degasa SA De CV
Strength
75 mg/mL
Dosage Form
SOLUTION
Route
TOPICAL
Marketing Status
Application #
505G(a)(3)
Drug Class
Antiseptic [EPC]
Marketing Start
08/13/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

off label use268 reports
endophthalmitis172 reports
drug ineffective160 reports
nausea153 reports
pain148 reports
rash148 reports
drug hypersensitivity128 reports
product use in unapproved indication124 reports
confusional state112 reports
type 2 diabetes mellitus112 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Patient preoperative skin preparation: Surgical hand scrub: For preparation of the skin prior to surgery Helps reduce bacteria that potentially can cause skin infection Significantyl reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care

Dosage & Administration

Directions Patient preoperative skin preparation: Surgical hand scrub: Clean the area Apply product to the operative site prior to surgery Scrub thoroughly for 5 minutes Rinse off with a sterile gauze saturated with water Clean under nails with a nail pick. Nail should be maintained with a 1 millimeter free edge Wet hands and forearms Apply 5 millileters (teaspoonful) or palmfull to hands and forearms Scub thoroughly for 5 minutes with a sterile brush Paying particular attention to the nails, cuticles, and interdigital spaces Rinse and repeat scrub

Warnings

WARNINGS: For External Use Only Do not use Stop use and ask a doctor if In the eyes Heat prior to application On individuals who are allergic or sensitive to Iodine Irritation and redness develop If condition persists for more than 72 hous consult a doctor Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away

Frequently Asked Questions

What is Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub used for?

Povidone-iodine is an antiseptic solution used to clean and disinfect skin before surgery and medical procedures, as well as for surgical hand scrubbing. It is available over-the-counter as a topical preparation applied directly to the skin.

Is Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub a controlled substance?

Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub is not classified as a controlled substance by the DEA.

What is the generic name for Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub?

The generic name for Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub is POVIDONE-IODINE. There are 12 other brand versions of POVIDONE-IODINE.

What is the NDC code for Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub 75 mg/mL?

The NDC (National Drug Code) for Antiseptic Patient Preoperative Skin Preparation and Surgical Hand Scrub 75 mg/mL is 67326-352, listed by Degasa SA De CV.