Label: APLICARE POVIDONE-IODINE- povidone-iodine douche
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Contains inactivated NDC Code(s)
NDC Code(s): 52380-1730-2, 52380-1730-8 - Packager: Aplicare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 Label Information
Updated April 26, 2010
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- WARNINGS
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STOP USE
Stop use and ask a doctor if
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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
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- ASK DOCTOR
- DOSAGE & ADMINISTRATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
APLICARE POVIDONE-IODINE
povidone-iodine doucheProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-1730 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Povidone-iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Povidone-iodine 10 g in 100 g Inactive Ingredients Ingredient Name Strength Nonoxynol-10 (UNII: K7O76887AP) Glycerin (UNII: PDC6A3C0OX) Dimethicone (UNII: 92RU3N3Y1O) Silicon Dioxide (UNII: ETJ7Z6XBU4) Sodium Phosphate, Dibasic Anhydrous (UNII: 22ADO53M6F) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52380-1730-2 60 g in 1 BOTTLE 2 NDC:52380-1730-8 240 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 09/01/1998 Labeler - Aplicare, Inc. (107255002) Establishment Name Address ID/FEI Business Operations Aplicare, Inc. 058377631 manufacture