Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Changzhou Maokang Medical Products Co., Ltd
TOPICAL
OTC DRUG
for antiseptic skin preparation
OTC monograph not final
POVIDONE-IODINE SCRUB SOLUTION- POVIDONE-IODINE SOLUTION CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD ---------- POVIDONE-IODINE SCRUB SOLUTION _DRUG FACTS_ _ACTIVE INGREDIENT_ Povidone-Iodine 7.5%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 persist 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._ _DIRECTIONS_ apply locally as needed _OTHER INFORMATION_ 0.75% titratable iodine for hospital or professional use only _INACTIVE INGREDIENTS:_ Hydroxyethyl cellulose, nonoxynol-10, alkyl glucoside, potassium iodide, sodium hydroxide, glycerin, citric acid, purifed water PACKAGE LABELING: POVIDONE-IODINE SCRUB SOLUTION povidone-iodine solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:59050-559 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRENGTH POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 75 mg in 1 mL 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) Changzhou Maokang Medical Products Co., Ltd GLYCERIN (UNII: PDC6A3C0OX) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:59050-559- 64 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 06/10/2020 MARKETING INFORMATION MARKETING CATEGORY APPLICATION NUMBER OR MONOGRAPH CITATION MARKETING START DATE MARKETING END DATE OTC Monograph Drug 505G(a)(3) 06/10/2020 LABELER - Changzhou Maokang Medical Products Co., Ltd (421317073) Revised: 11/2023 Leggi il documento completo