Kraj: Stany Zjednoczone
Język: angielski
Źródło: NLM (National Library of Medicine)
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)
LernaPharm Loris Inc.
TOPICAL
OTC DRUG
Antiseptic
OTC monograph final
POVIDONE-IODINE - POVIDONE-IODINE SWAB LERNAPHARM LORIS INC. _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 ACTIVE INGREDIENTS (IN EACH SWAB) Povidone Iodine 10% w/v PURPOS E Antiseptic US ES First aid to reduce the risk of skin infection in minor cuts, scrapes and burns. WARNINGS FOR EXTERNAL USE ONLY OTC -DO NOT USE SECTION DO NOT USE in the eyes ● Apply over a large areas of the body ● In case of deep puncture wounds, animal bites, or serious burns, consult a doctor. OTC -STOP USE SECTION STOP USE AND CONSULT A DOCTOR if the condition persists or gets worse. OTHER REQUIRED WARNINGS Do not use longer than 1 week unless directed by the doctor. DIRECTIONS ● Clean the affected area ● Apply a small amount of this product on the area 1 to 3 times daily. ● May be covered with a sterile bandage ● If bandaged, let dry first. OTHER INFORMATION Store at room temperature between 59 - 86 F (15 - 30 C) INACTIVE INGREDIENTS Purified water, sodium hydroxide solution, copovidone, glycerol, sodium lauryl sulfate, phosphorous, sodium citrate 0 0 PRINCIPAL DISPLAY PANEL NDC: 68356-109-01 PRODUCT # 109-01U LORIS 10% PVP - I SOLUTION MEDIUM 200 Antiseptic swabs saturated with 10% W/V Povidone Iodine solution, USP (equivalent to 1% available iodine) 200 For external Use Only POVIDONE-IODINE povidone-iodine swab PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:6 8 356 -10 9 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 .0 5 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH WATER (UNII: 0 59 QF0 KO0 R) LernaPharm Loris Inc. SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I) CO PO VIDO NE (UNII: D9 C330 MD8 B) GLYCERIN (UNII: PDC6 A3C0 OX) SO DIUM LAURYL SULFATE (UNII: 36 8 GB5141 Przeczytaj cały dokument