Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)
Shandong Haiyan Medical Manufacture Co., Ltd.
POVIDONE-IODINE
POVIDONE-IODINE 9.43 g in 100 g
TOPICAL
OTC DRUG
OTC monograph final
POVIDONE-IODINE PAD - POVIDONE-IODINE SWAB SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD. _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._ ---------- ANTISEPTIC POVIDONE-IODINE PREP PAD 10% POVIDONE-IODINE, 1% AVAILABLE IODINE. SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD. WWW. HAIYAN-MEDICAL.COM ACTIVE INGREDIENT Povidone Iodine 10% w/w (equivalent to iodine 1%) PURPOS E Antiseptic US E Antiseptic for preparation of the skin. WARNINGS For external use only. Discontinue use if irritation and redness develop. Keep out of reach of Children. DIRECTIONS Apply locally as needed. Other Information Store at room temperature: 59°- 86°F(15 - 30 ) INACTIVE INGREDIENTS Purified Water Shandong Haiyan Medical Manufacture Co., Ltd. POVIDONE-IODINE PAD povidone-iodine swab PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:42339 -0 0 2 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) (POVIDONE-IODINE - UNII:8 5H0 HZU9 9 M) POVIDONE-IODINE 9 .43 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP) SO DIUM PHO SPHATE (UNII: SE337SVY37) WATER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:42339 -0 0 2-0 1 10 in 1 CONTAINER 1 10 0 in 1 BOX 1 0 .6 g in 1 POUCH 2 NDC:42339 -0 0 2-0 2 10 0 in 1 CONTAINER 2 10 0 in 1 BOX 2 0 .6 g in 1 POUCH MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE OTC mo no graph final pa rt333C 0 2/18 /20 12 LABELER - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Shando ng Haiyan Medical Manufacture Co ., Ltd. 42128 3439 ma nufa c ture Revised: 3/2012 Baca dokumen lengkap