Label: APLICARE POVIDONE-IODINE- povidone-iodine solution
- NDC Code(s): 52380-1721-1
- Packager: Aplicare Products, LLC
- Category: HUMAN OTC DRUG LABEL
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.
Updated December 1, 2021
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- Active ingredient
For external use only.
Stop use and ask a doctor if
• infection occurs
• redness, irritation, swelling or pain persists or increases
- Other information
- Inactive ingredients
- Questions or comments?
- Manufacturing Information
- Package Label
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-1721 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 NONOXYNOL-10 (UNII: K7O76887AP) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52380-1721-1 0.65 mL in 1 PACKET; Type 0: Not a Combination Product 09/01/1998 11/06/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 09/01/1998 11/06/2022 Labeler - Aplicare Products, LLC (081054904) Registrant - Medline Industries, LP (025460908)