País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Clint Pharmaceuticals, Inc.
Premarket Notification
ACL5 SINGLE SHOT EPIDURAL - REGIONAL ANESTHESIA KIT CLINT PHARMACEUTICALS, INC. ---------- DRUG FACTS APLICARE THREE POVIDONE-IODINE SWABSTICKS [Aplicare, Inc.] Three 4-inch saturated swabsticks Povidone-iodine 10% Antiseptic Warnings 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 Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately. Package Label Display Panel ACL5 SINGLE SHOT EPIDURAL regional anesthesia kit kit PRODUCT INFORMATION PRODUCT T YPE MEDICAL DEVICE ITE M CODE (SOURCE ) NHRIC:55553-446 PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NHRIC:55553-446 -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 6 .5 mL PART 1 OF 1 APLICARE POVIDONE-IODINE TRIPLES povidone-iodine solution PRODUCT INFORMATION ITE M CODE (SOURCE ) NDC:5238 0 -310 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) POVIDONE-IODINE 9 .8 g in 9 6 .4 mL INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH SO DIUM PHO SPHATE, DIBASIC (UNII: GR6 8 6 LBA74) CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) 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 -310 1-5 6 .5 mL in 1 PACKET MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph no t final pa rt333A 0 3/0 1/19 9 8 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITA Llegiu el document complet