Label: POVIDONE IODINE- povidone iodine gargle 0.5% liquid
- NDC Code(s): 0395-9128-98
- Packager: Humco Holding Group, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 15, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
- Warnings
- Stop use and consult a doctor if
- When using this product do not
- Keep out of reach of children.
- Directions
- Other information
- Inactive Ingredients
- Do not use this product
- If pregnant or breast-feeding
- Purdue Gargle Label
-
INGREDIENTS AND APPEARANCE
POVIDONE IODINE
povidone iodine gargle 0.5% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9128 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 5 mg in 1 mL Inactive Ingredients Ingredient Name Strength MENTHOL (UNII: L7T10EIP3A) SACCHARIN SODIUM (UNII: SB8ZUX40TY) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) GLYCERIN (UNII: PDC6A3C0OX) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PEPPERMINT (UNII: V95R5KMY2B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0395-9128-98 1 in 1 CARTON 06/10/2020 1 237 mL in 1 CONTAINER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 06/10/2020 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(0395-9128) , analysis(0395-9128) , pack(0395-9128) , label(0395-9128)