Drug Facts Box Otc Active Ingredient Section
Povidone Iodine USP 10%
equivalent to 1% titratable iodine
Certus Pvp-1 Prep Swabstick
FDA Label NDC 75990-4019
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Certus Medical, Inc. for the product Certus Pvp-1 Prep Swabstick (NDC 75990-4019). 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 drug facts box otc active ingredient section, drug facts box otc purpose section, drug facts box otc indications & usage section, drug facts box otc warnings section, drug facts box otc do not use section, drug facts box otc ask doctor section, drug facts box otc stop use section, drug facts box otc keep out of reach of children section, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Drug Facts Box Otc Purpose Section
Antiseptic
Drug Facts Box Otc Indications & Usage Section
health-care antiseptic for preparation of the skin prior to surgery
Drug Facts Box Otc Warnings Section
For external use only
Drug Facts Box Otc Do Not Use Section
in the eyes
over large areas of the body
on individuals who are allergic or sensitive to iodine
Drug Facts Box Otc Ask Doctor Section
in case of deep or puncture wounds, animal bites, or serious burns
Drug Facts Box Otc Stop Use Section
and consult a doctor if redness, irritation, swelling, or pain persists or increases
Drug Facts Box Otc Keep Out Of Reach Of Children Section
in case of accidental ingestion, seek professional assistance or consult a Poison Control Center immediately
Drug Facts Box Otc Dosage & Administration Section
for preparation of the skin prior to surgery
remove swab by stick
clean the area
apply product to the operative site prior to surgery
Drug Facts Box Otc General Precautions Section
store at room temperature 150 - 300 C (590 - 860 F)
Drug Facts Box Otc Inactive Ingredient Section
disodium phosphate, glycerin, hydroxyethylcellulose, nonoxynol-10, dimethicone, water
Certus Pvp-1 Prep Swabstick 210012 Pouch
210012.jpg Certus PVP-1 Prep Swabstick pouch
Image Of Pouch Label (210012)
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