Label: POVIDONE IODINE- povidone iodine oral rinse 0.5% liquid
- NDC Code(s): 0395-9136-23, 0395-9136-98
- 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.
Updated March 17, 2022
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Stop use and consult a doctor if
- When using this product do not
- Keep out of reach of children.
- Use full strength.
- Apply 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse for 30 seconds and then spit out.
- Wait 2 minutes, and apply another 10 to 20 milliliters of solution to the operative site. Instruct the patient to rinse again for 30 seconds and then spit out.
- With a standard syringe and a blunt, angulated needle, irrigate the operative site and the surrounding gingival mucosa for 1 minute with 10 to 20 milliliters of the solution. Instruct the patient to spit out the solution after the irrigation procedure.
- Other information
- Inactive Ingredients
- Do not use this product
- If pregnant or breast-feeding
- Purdue Oral Rinse Label
INGREDIENTS AND APPEARANCE
povidone iodine oral rinse 0.5% liquid
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0395-9136 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:0395-9136-98 237 mL in 1 CONTAINER; Type 0: Not a Combination Product 01/06/2021 2 NDC:0395-9136-23 20 mL in 1 CONTAINER; Type 0: Not a Combination Product 10/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 01/06/2021 Labeler - Humco Holding Group, Inc. (825672884) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(0395-9136) , analysis(0395-9136) , pack(0395-9136) , label(0395-9136)