מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Changzhou Maokang Medical Products Co., Ltd
POVIDONE-IODINE
IODINE 100 mg in 1 g
TOPICAL
OTC DRUG
for antiseptic skin preparation
OTC monograph not final
MK POVIDONE IODINE SWABSTICK STERILE- POVIDONE-IODINE PATCH CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD ---------- MK POVIDONE IODINE SWABSTICK STERILE _DRUG FACTS_ _ACTIVE INGREDIENT_ Povidone-Iodine 10% w/w _PURPOSE_ Antiseptic _USE_ for antiseptic skin preparation _WARNINGS_ DO NOT USE If allergic to Iodine do not use in the eye 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. Avoid pooling beneath patient. _ASK A DOCTOR BEFORE USE IF INJURIES ARE._ injuries are deep or puncture wounds serious burns _DIRECTIONS_ apply locally as needed. _OTHER INFORMATION_ 1% titratable iodine for hospital or professional use only _INACTIVE INGREDIENTS:_ Hydroxyethyl cellulose, nonexynol-10, alkyl glucoside, potassium iodide, sodium hydroxide, glycerin, citric acid, purified water. PACKAGE LABELING: MK POVIDONE IODINE SWABSTICK STERILE povidone-iodine patch PRODUCT INFORMATION Changzhou Maokang Medical Products Co., Ltd PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:59050-258 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 100 mg in 1 g INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D) NONOXYNOL-10 (UNII: K7O76887AP) POTASSIUM IODIDE (UNII: 1C4QK22F9J) SODIUM HYDROXIDE (UNII: 55X04QC32I) GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:59050- 258-11 2.5 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 09/27/2017 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug 505G(a)(3) 09/27/2017 LABELER - Chang קרא את המסמך השלם