Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Aplicare Products, LLC
TOPICAL
OTC DRUG
Antiseptic antiseptic skin preparation
OTC monograph not final
APLICARE POVIDONE-IODINE TRIPLES- POVIDONE-IODINE SOLUTION APLICARE PRODUCTS, LLC _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._ ---------- 3101 APLICARE POVIDONE-IODINE TRIPLES _ACTIVE INGREDIENT_ Povidone-iodine 10% (equivalent to 1% available iodine) _PURPOSE_ Antiseptic _USE_ antiseptic skin preparation _WARNINGS_ FOR EXTERNAL USE ONLY AVOID POOLING BENEATH PATIENT AVOID EXCESSIVE HEAT. STORE AT ROOM TEMPERATURE. 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 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 single use only • not made with natural rubber latex • for hospital or professional use only _INACTIVE INGREDIENTS_ citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water MANUFACTURING INFORMATION Manufactured for: Medline industries, LP Three Lakes Drive, Northfield, IL 60093 USA Manufactured by: Aplicare Products, LLC 550 Research Parkway, Merident, CT 06450 USA 1-800-633-5463 REF: APLS31015S PACKAGE LABEL APLICARE POVIDONE-IODINE TRIPLES povidone-iodine solution PRODUCT INFORMATION PRODUCT TYPE HUMAN OTC DRUG ITEM CODE (SOURCE) NDC:52380-3101 ROUTE OF ADMINISTRATION TOPICAL Aplicare Products, LLC 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 SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM HYDROXIDE (UNII: 55X04QC32I) NONOXYNOL-9 (UNII: 48Q180S Прочитайте повний документ