Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Aplicare Products, LLC
TOPICAL
OTC DRUG
Antiseptic antiseptic skin preparation
OTC monograph not final
APLICARE POVIDONE-IODINE- POVIDONE-IODINE SOLUTION APLICARE PRODUCTS, LLC ---------- 0011 POVIDONE-IODINE (NONSTERILE) _ACTIVE INGREDIENT_ Povidone-iodine USP 10% _PURPOSE_ Antiseptic _USE_ antiseptic skin preparation _WARNINGS_ For external use only Avoid pooling beneath patient Avoid excessive heat. Store at room temperature DO NOT USE • if allergic to iodine • in the eyes 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 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_ • 1% titratable iodine • 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 Parkway, Meriden, CT 06450 Made in USA 1-800-633-5463 0117 PACKAGE LABEL APLICARE POVIDONE-IODINE povidone-iodine solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:52380-0011 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY Aplicare Products, LLC 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) NONOXYNOL-9 (UNII: 48Q180SH9T) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:52380- 0011-1 30 mL in 1 PACKET; Type 0: Not a Combination Product 05/31/2017 11/30/2025 2 NDC:52380- 0011-3 22.5 mL in 1 PACKET; Type 0: Not a Combination Product 05/31/2017 09/30/2026 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAP Belgenin tamamını okuyun