Label: POVIDONE IODINE- povidone-iodine spray 5% liquid
- NDC Code(s): 0395-9129-93
- Packager: Humco Holding Group, 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 December 30, 2022
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- Active Ingredient
- Warnings
- Do not use:
- Ask a doctor before use if you have:
- Stop and ask a doctor if:
- Keep out of reach of children
- Other Information
- Inactive ingredients:
- Directions:
- Uses
- Purpose
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INGREDIENTS AND APPEARANCE
POVIDONE IODINE
povidone-iodine spray 5% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9129 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength POTASSIUM IODATE (UNII: I139E44NHL) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) POLOXAMER 407 (UNII: TUF2IVW3M2) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-9129-93 89 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/23/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/23/2020 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(0395-9129) , pack(0395-9129) , label(0395-9129) , analysis(0395-9129)