Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Aplicare Products, LLC
TOPICAL
OTC DRUG
Antiseptic - • antiseptic skin preparation - • single use when used for patient preoperative skin preparation
OTC monograph not final
APLICARE POVIDONE-IODINE- POVIDONE-IODINE SOLUTION APLICARE PRODUCTS, LLC ---------- 2801APLICARE POVIDONE IODINE SOLUTION _ACTIVE INGREDIENT_ Povidone-iodine 10% (equivalent to 1% available iodine) _PURPOSE_ Antiseptic _USE_ • antiseptic skin preparation • single use when used for patient preoperative skin preparation _WARNINGS_ FOR EXTERNAL USE ONLY AVOID "POOLING" BENEATH PATIENT. PROLONGED EXPOSURE TO WET SOLUTION MAY CAUSE SKIN IRRITATION. DO NOT USE • in the eyes • on individuals allergic or sensitive to iodine ASK A DOCTOR BEFORE USE IF INJURIES ARE • deep or puncture wounds • serious burns STOP USE AND ASK A DOCTOR IF • infection occurs • redness, irritation, swelling or pain persists or increases KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately. _DIRECTIONS_ apply locally as needed _OTHER INFORMATION_ • not made with natural rubber latex • for hospital or professional use only _INACTIVE INGREDIENTS_ citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water MANUFACTURING INFORMATION Manufactured by: Aplicare Products, LLC 550 Research Way, Meriden, CT 06450 USA Made in USA REF: APL82342K RL17HND PACKAGE LABEL APLICARE POVIDONE-IODINE povidone-iodine solution Aplicare Products, LLC PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:52380-2801 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) SODIUM HYDROXIDE (UNII: 55X04QC32I) NONOXYNOL-9 (UNII: 48Q180SH9T) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:52380- 2801-8 59 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/1998 MARKETING INFORMATION MARKETING CATEGORY APPLICATION Lesen Sie das vollständige Dokument