Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
Wuxi Medical Instrument Factory
TOPICAL
OTC DRUG
Purpose First Aid Antiseptic Do not * use in the eyes * apply over large areas of the body * use on individuals who are allergic or sensitive to iodine Stop use and consult a doctor if the condition persists or gets worse for use longer than 1 week Directions Clean the affected area Apply product on the area 1-3 times daily and discard May be covered with a sterile bandage when dry
OTC monograph final
POVIDONE-IODINE PREP PAD - POVIDONE-IODINE SWAB WUXI MEDICAL INSTRUMENT FACTORY _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._ ---------- DRUG FACTS ITEM# 83791-817-030 NDC# 42947-611-10 QTY. 1EA POVIDONE-IODINE PREP PAD Antiseptic/Germicide, Medium*For Single Use Only Saturated with a 10% povidone-iodine solution equivalent to 1% titratable iodine FOR EXTERNAL USE ONLY Manufactured by: Wuxi Medical Instrument Factory No.86 East street, Zhangjing, Wuxi, Jiangsu 214194 China Made in China ACTIVE INGREDIENT Povidone Iodine USP, 10% w/v (equivalent to 1% titratable iodine) PURPOS E First Aid Antiseptic US E First aid to help prevent infection in minor cuts, scrapes, and burns WARNINGS For external use only. DO NOT * use in the eyes * apply over large areas of the body * use on individuals who are allergic or sensitive to iodine STOP USE AND CONSULT A DOCTOR if the condition persists or gets worse for use longer than 1 week ASK A DOCTOR in case of deep or puncture wounds, animal bites, serious burns. KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or contact Poison Control Center right away. DIRECTIONS Clean the affected area Apply product on the area 1-3 times daily and discard May be covered with a sterile bandage when dry INACTIVE INGREDIENTS ctric acid, glycerin, Nonoxynol-10, purified water, sodium hydroxide POVIDONE-IODINE PREP PAD povidone-iodine swab PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:429 47-6 11 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (IODINE - UNII:9 6 79 TC0 7X4) POVIDONE-IODINE 0 .1 mL in 1 mL Wuxi Medical Instrument Factory PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:429 47-6 11-10 0 .5 mL in 1 POUCH MARKETING INFORMATION MARKE TING CATE GOR Lugege kogu dokumenti