Label: APLICARE POVIDONE-IODINE SCRUB- povidone-iodine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 52380-0025-6, 52380-0025-9 - 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 January 5, 2010
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- PRINCIPAL DISPLAY PANEL
- ACTIVE INGREDIENT
- PURPOSE
- ASK DOCTOR
- DO NOT USE
- KEEP OUT OF REACH OF CHILDREN
- QUESTIONS
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INGREDIENTS AND APPEARANCE
APLICARE POVIDONE-IODINE SCRUB
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-0025 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) POVIDONE-IODINE 8.1 g in 100 g Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SODIUM HYDROXIDE (UNII: 55X04QC32I) NONOXYNOL-9 (UNII: 48Q180SH9T) AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52380-0025-6 2 g in 1 PACKET 2 NDC:52380-0025-9 8 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333 01/01/1984 Labeler - Aplicare, Inc. (107255002) Establishment Name Address ID/FEI Business Operations Aplicare, Inc. 107255002 manufacture
