Label: APLICARE POVIDONE-IODINE SCRUB LARGE WING SPONGE- povidone-iodine scrub solution
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Contains inactivated NDC Code(s)
NDC Code(s): 52380-0124-2 - 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 May 31, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Use
- Warnings
- Directions
- Other information
- Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL - 2 Sponge Packet
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INGREDIENTS AND APPEARANCE
APLICARE POVIDONE-IODINE SCRUB LARGE WING SPONGE
povidone-iodine scrub solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-0124 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (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:52380-0124-2 120 mL in 1 PACKET; Type 0: Not a Combination Product 05/31/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 05/31/2017 Labeler - Aplicare, Inc. (107255002) Establishment Name Address ID/FEI Business Operations Aplicare, Inc. 107255002 manufacture(52380-0124)