Label: APLICARE POVIDONE-IODINE- povidone-iodine solution
- NDC Code(s): 52380-0001-1, 52380-0001-3, 52380-0001-5
- Packager: Aplicare Products, LLC
- 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 December 15, 2022
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- Active Ingredient
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INGREDIENTS AND APPEARANCE
APLICARE POVIDONE-IODINE
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-0001 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) NONOXYNOL-9 (UNII: 48Q180SH9T) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52380-0001-1 30 mL in 1 PACKET; Type 0: Not a Combination Product 02/15/2018 03/31/2020 2 NDC:52380-0001-3 22.5 mL in 1 PACKET; Type 0: Not a Combination Product 02/15/2018 05/31/2025 3 NDC:52380-0001-5 0.5 mL in 1 PACKET; Type 0: Not a Combination Product 02/15/2018 07/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 03/01/1984 05/31/2025 Labeler - Aplicare Products, LLC (081054904) Registrant - Medline Industries, LP (025460908)