Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Owens & Minor Distribution, Inc.
TOPICAL
OTC DRUG
Antiseptic skin preparation
OTC monograph final
POVIDONE-IODINE PREP- POVIDONE-IODINE SOLUTION OWENS & MINOR DISTRIBUTION, INC. ---------- POVIDONE-IODINE PREP SOLUTION _DRUG FACTS_ _ACTIVE INGREDIENT_ Povidone-iodine USP 10% _PURPOSE_ Antiseptic _USE_ Antiseptic skin preparation _WARNINGS_ FOR EXTERNAL USE ONLY DO NOT USE • if allergic to iodine • in the eyes ASK A 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 AVOID POOLING BENEATH PATIENT AVOID EXCESSIVE HEAT. STORE AT ROOM TEMPERATURE. KEEP OUT OF REACH OF CHILDREN. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately. _DIRECTIONS_ Apply locally as needed _OTHER INFORMATION_ • 1% titratable iodine • for hospital or professional use only _INACTIVE INGREDIENTS_ Purified water, Glycerin, Nonyl nonoxynol-10 PACKAGE LABELING: POVIDONE-IODINE PREP povidone-iodine solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:39892-0809 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 mL INACTIVE INGREDIENTS INGREDIENT NAME STRENGTH WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PACKAGING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:39892- 0809-1 1.5 mL in 1 PACKET; Type 0: Not a Combination Product 03/01/2019 MARKETING INFORMATION MARKETING APPLICATION NUMBER OR MONOGRAPH MARKETING START MARKETING END Owens & Minor Distribution, Inc. CATEGORY CITATION DATE DATE OTC Monograph Drug M005 03/01/2019 LABELER - Owens & Minor Distribution, Inc. (847412269) Revised: 12/2023 Lesen Sie das vollständige Dokument