Otc - Active Ingredient
Active Ingredient Purposes
Povidone Iodine 7.5% w/w .............. Antiseptic
Foam Safe
FDA Label NDC 47066-402
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gremed Manufacturing Llc for the product Foam Safe (NDC 47066-402). 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 otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.
Warnings
Warnings
For External Use Only
Stope use and ask doctor if irritation or redness develops.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions
Clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge. Wet hands and forearms. Apply a palmful (5g) of foam to hands and forearms. Scrub thoroughly for 2 minutes with a sterile scrub brush, paying particular attention to the nails, cuticles and interdigital spaces. Rinse and repeat scrub.
Inactive Ingredient
Inactive Ingredients
Water, Lauramide DEA, Ammonium Lauryl Sulfate, PEG-7, Glyceryl Cocoate, Panthenol, Sodium Hydroxide, Potassium Iodate
Package Label.Principal Display Panel
Foamsafelabel (Foamsafe)
Indications & Usage
If swallowed, get medical help or contact a poison control center right away. Avoid contact with eyes; in case of contact, flush eyes with water.
* Please review the disclaimer below.
