Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Clint Pharmaceuticals, Inc.
APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution [Aplicare, Inc.] 3/4 Ounce Povidone Iodine Packet
Premarket Notification
ACS22Q45 NERVE BLOCK - REGIONAL ANESTHESIA KIT CLINT PHARMACEUTICALS, INC. ---------- APLICARE POVIDONE-IODINE SOLUTION (povidone-iodine solution) solution [Aplicare, Inc.] 3/4 Ounce Povidone Iodine Packet 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 professionalassistance or consult a poison control center immediately. Package Label Display Panel Package Label Display Panel ACS22Q45 NERVE BLOCK regional anesthesia kit kit PRODUCT INFORMATION PRODUCT T YPE MEDICAL DEVICE ITE M CODE (SOURCE ) NHRIC:55553-457 PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NHRIC:55553-457-0 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 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 8 4 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR M Lees het volledige document