Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: 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 _Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may_ _be marketed if they comply with applicable regulations and policies. FDA has not_ _evaluated whether this product complies._ ---------- 1721 APLICARE NON-STERILE POVIDONE-IODINE PREP SWABS, 10% _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. DO NOT USE in the eye on individuals allergic or sensitive to iodine ASK 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_ Reverse cardboard sleeve then crush at dot between thumb and forefinger Reverse cardboard sleeve then crush at dot between thumb and forefinger Allow solution to saturate tip apply topically 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 _QUESTIONS OR COMMENTS?_ 1 800 633 5463 MANUFACTURING INFORMATION Manufactured for: Aplicare Products, LLC 550 Research Parkway, Meriden, CT 06450 USA Made in USA REF: APL82278 RA19J-A PACKAGE LABEL Aplicare Products, LLC APLICARE POVIDONE-IODINE povidone-iodine solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:52380-1721 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 NONOXYNOL-10 (UNII: K7O76887AP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SO Đọc toàn bộ tài liệu