Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Jianerkang Medical Co., Ltd
TOPICAL
OTC DRUG
Purpose Antiseptic Uses Prepping intact skin and mucous membranes prior to surgery Stop use and ask a doctor if Skin shows symptoms of irritation, sensitivity, redness, pain or swelling Directions Patient preoperative prep use full strength apply solution to operative site following povidone iodine scrub application using a circular motion, start at incision site and move outward remove all soiled underdrapes do not allow solution to pool
OTC monograph final
POVIDONE IODINE- POVIDONE IODINE SOLUTION JIANERKANG MEDICAL CO., LTD ---------- DRUG FACTS ACTIVE INGREDIENTS Povidone Iodine, USP 10% (1.0% available Iodine) PURPOSE Antiseptic USES Prepping intact skin and mucous membranes prior to surgery WARNINGS For external use only Avoid use on persons allergic to iodine STOP USE AND ASK A DOCTOR IF Skin shows symptoms of irritation, sensitivity, redness, pain or swelling KEEP OUT OF REACH OF CHILDREN If swallowed, get medical help or contact Poison Control Center right away DIRECTIONS Patient preoperative prep use full strength apply solution to operative site following povidone iodine scrub application using a circular motion, start at incision site and move outward remove all soiled underdrapes do not allow solution to pool OTHER INFORMATION store at room temperature avoid excessive heat (above 104oF/40oC) protect from freezing latex free INACTIVE INGREDIENTS Citric Acid, Glycerin, Nonoxynol - 10, Purified Water, Sodium hydroxide, hydroxyethylcellulose PACKAGE LABEL POVIDONE IODINE povidone iodine solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:34645-4188 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) GLYCERIN (UNII: PDC6A3C0OX) NONOXYNOL-10 (UNII: K7O76887AP) Jianerkang Medical Co., Ltd WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:34645- 4188-6 88.5 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2010 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug M005 01/01/2010 LABELER - Jianerkang Medical Co., Ltd (530968767) Revised: 10/2023 Belgenin tamamını okuyun