Active Ingredient
Povidone-iodine 7.5%
Provodine
FDA Label NDC 59426-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Microdermis Corporation for the product Provodine (NDC 59426-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic
Uses
■ Patient Preoperative Skin Preparation: for preparation of the skin prior to a procedure. Helps reduce bacteria that potentially can cause skin infection.
■ Surgical Hand Scrub: significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
■ Healthcare Personnel Handwash: for handwashing to decrease bacteria on the skin after assisting ill persons.
Warnings
For external use only
Do not use in the eyes
Stop Use And Ask A Doctor If
irritation and redness develop. If condition persists for more than 72 hours consult a doctor.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Surgical Hand Scrub:
■ Clean under nails with a nail pick.
■ Nails should be maintained with a 1 millimeter free edge.
■ Wet hands and forearms. ■ Apply 5 milliliters (teaspoonful) or palmful to hands and forearms.
■ Scrub thoroughly for 60 seconds, paying particular attention to the nails, cuticles, and interdigital spaces.
■ Rinse and repeat scrub. ■ Dry with a clean towel.
Patient Preoperative Skin Preparation:
■ Clean the area.
■ Apply product to the operative site prior to surgery.
■ 1 mL (dime size) covers an estimated 5”x5” area.
■ Let dry 1-2 minutes.
Healthcare Personnel Handwash Without Water:
■ Place a smaller amount (3 mLs) of product in onehand.
■ Spread over both hands to wrist and rub into
the skin until dry (approximately 30 seconds).
Healthcare Personnel Handwash With Water:
■ Wet clean hands and wrists.
■ Apply 3 milliliters into one hand and spread over both hands to wrist.
■ Rub thoroughly for 30 seconds.
■ Let dry for 30 seconds.
■ Rinse for 30 seconds.
■ Dry with a clean towel.
Other Information
Store in a cool dry place, between 20°-25° C (66°-77° F)
Avoid freezing and excessive heat above 40° C (104° F)
Inactive Ingredients
Allantoin, Beeswax, Benzalkonium Chloride, Butylene, Glycol, C13-14 Isoparaffin, Caprylic/Capric, Triglyceride, Cetyl Alcohol, Disodium EDTA, Distearyl, Dimonium Chloride, Emulsifying Wax, NF, Glyceryl, Laurate, Glyceryl Stearate, Hydrogenated Jojoba Esters, Laureth-7, Nonoxynol-9, Octoxynol-9, PCA, PEG-100 Stearate, Polyacrylamide, Polyglyceryl-3 Diisostearate, Polyquaternium-7, Purified Water, Sclerotium Gum, Stearic Acid, Triethanolamine.
Questions?
Call (877) 710-6958 www.microdermis.com
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