Krajina: Spojené štáty
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
Povidone-iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4)
Aplicare, Inc.
VAGINAL
OTC DRUG
Antiseptic For temporary relief of minor itching and irritation Stop use and ask a doctor if - symptoms persist for more than 7 days you have pain or tenderness in the lower part of the abdomen and pelvis symptoms persist for more than 7 days you have pain or tenderness in the lower part of the - you have vaginal discharge or bleeding, chills, nausea, or fever - your vaginal discharge is an unusual amount, color or odor - you have frequent and painful urination - douching results in pain, soreness, swelling, redness, itching, excessive dryness or irritation
OTC monograph not final
APLICARE POVIDONE-IODINE - POVIDONE-IODINE DOUCHE APLICARE, 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 Povidone-Iodine USP 10% (0.16% when diluted) Antiseptic For temporary relief of minor itching and irritation Do not use if sensitive to iodine For vaginal use only Stop use and ask a doctor if symptoms persist for more than 7 days you have pain or tenderness in the lower part of the abdomen and pelvis you have vaginal discharge or bleeding, chills, nausea, or fever your vaginal discharge is an unusual amount, color or odor you have frequent and painful urination douching results in pain, soreness, swelling, redness, itching, excessive dryness or irritation If pregnant or breast-feeding, ask a health professional before use Use twice weekly unless directed by a physician. Add 1/2 fluid ounce (one tablespoonful) to 1 quart of lukewarm water. For other uses consult a physician. Questions or comments? 1 800 760-3236 (M-F 8:30 AM - 5:00 PM EST) Povidone-iodine Douche APLICARE POVIDONE-IODINE povidone-iodine douche PRODUCT INFORMATION PRODUCT T YPE HUMAN OTC DRUG ITE M CODE (SOURCE ) NDC:5238 0 -1730 ROUTE OF ADMINISTRATION VAGINAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PO VIDO NE-IO DINE (UNII: 8 5H0 HZU9 9 M) (Io dine - UNII:9 6 79 TC0 7X4) Po vido ne -io dine 10 g in 10 0 g INACTIVE INGREDIENTS INGREDIENT NAME STRE NG TH NO NO XYNO L-10 (UNII: K7O76 8 8 7AP) GLYCERIN (UNII: PDC6 A3C0 OX) DIMETHICO NE (UNII: 9 2RU3N3Y1O) SILICO N DIO XIDE (UNII: ETJ7Z6 XBU4) SO DIUM PHO SPHA TE, DIBA SIC ANHYDRO US (UNII: 22ADO53M6 F) WA TER (UNII: 0 59 QF0 KO0 R) PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:5238 0 -1730 -2 6 0 g in 1 BOTTLE 2 NDC:5238 0 -1730 -8 240 g in 1 BOTTLE Aplicare, Inc. MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MON Prečítajte si celý dokument