Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)
Mazza Healthcare, LLC
TOPICAL
OTC DRUG
Antiseptic - health care antiseptic for preparation of the skin prior to surgery - first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns
OTC monograph final
POVIDONE-IODINE- POVIDONE-IODINE SWAB MAZZA HEALTHCARE, LLC _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- DRUG FACTS ACTIVE INGREDIENT Povidone-Iodine, USP, 10% v/v (equivalent to 1% titratable iodine) PURPOSE Antiseptic USES health care antiseptic for preparation of the skin prior to surgery first aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns WARNINGS FOR EXTERNAL USE ONLY DO NOT USE in the eyes on individuals who are allergic or sensitive to iodine over large areas of the body as first aid antiseptic longer than 1 week unless directed by doctor DISCONTINUE USE IF irritation and redness develop. ASK A DOCTOR BEFORE USE IF YOU HAVE deep or puncture wounds, animal bites or serious burns. STOP USE AND CONSULT A DOCTOR IF the condition persists or gets worse. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. DIRECTIONS clean the affected area for preparation of the skin prior to surgery, apply product to the operative site apply product on the area 1-3 times daily. May be covered with a sterile bandage. If bandaged, let dry first. OTHER INFORMATION Store at room temperature 59-86ºF (15-30ºC). INACTIVE INGREDIENTS citric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide Mazza Healthcare, LLC 1-877-629-9242 PRINCIPAL DISPLAY PANEL - 500 POUCH CARTON LABEL MH Mazza Healthcare MODEL NO.: 02-053-00 DESCRIPTION: POVIDONE-IODINE SWABSTICKS, 4” SATURATED, NON-STERILE QUANTITY: 1 CASE (500 POUCHES X 3 EACH) LOT NO.: MANUFACTURE DATE: EXPIRY DATE: MANUFACTURED FOR: MAZZA HEALTHCARE, LLC BANNOCKBURN, IL 60015 • USA MADE IN CHINA NDC 81280-003-03 PRINCIPAL DISPLAY PANEL - 3 APPLICATORS POUCH LABEL MH Mazza Healthcare POVIDONE-IODINE SWABSTICKS NDC 81280-003-03 ANTISEPTIC • GERMICIDE • 4” SATURATED NON-STERILE • SINGLE USE ONLY Lugege kogu dokumenti