Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Clint Pharmaceuticals, Inc.
Antiseptic Antiseptic skin preparation Stop use and ask a doctor if -redness, irritation, swelling or pain persists or increases -infection occurs Avoid pooling beneath patient Avoid excessive heat. Store at room temperature. Apply locally as needed.
Premarket Notification
ACL4SP SINGLE SHOT EPIDURAL - REGIONAL ANESTHESIA KIT CLINT PHARMACEUTICALS, INC. ---------- DRUG FACTS Povidone-iodine Antiseptic Antiseptic skin preparation Do not use -if allergic to iodine -in the eyes For external use only Ask a doctor before use if injuries are -deep or puncture wounds -serious burns Stop use and ask a doctor if -redness, irritation, swelling or pain persists or increases -infection occurs Avoid pooling beneath patient Avoid excessive heat. Store at room temperature. Keep out of reach of children In case of accidental ingestion, seek professional assistance or consult a poison control center immediately. Apply locally as needed. 1% titratable iodine latex free for hospital or professional use only citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water 1 800 760-3236 (Mon to Fri 8:30 AM-5:00 PM EST) Package Label Display Panel Package Label Display Panel ACL4SP SINGLE SHOT EPIDURAL regional anesthesia kit kit PRODUCT INFORMATION PRODUCT T YPE MEDICAL DEVICE ITE M CODE (SOURCE ) NHRIC:55553-445 PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NHRIC:55553-445-0 2 30 in 1 CASE 1 1 in 1 PACKAGE, COMBINATION QUANTITY OF PARTS PART # PACKAGE QUANTITY TOTAL PRODUCT QUANTITY PA RT 1 1 PACKET 22.5 mL PART 1 OF 1 APLICARE POVIDONE-IODINE povidone-iodine solution PRODUCT INFORMATION ITE M CODE (SOURCE ) NDC:5238 0 -0 0 0 1 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4) IODINE 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74) SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I) NO NO XYNO L-9 (UNII: 48 Q18 0 SH9 T) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:5238 0 -0 0 0 1-3 22.5 mL in 1 PACKET MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUM Pročitajte cijeli dokument