Label: SUNMARK POVIDONE-IODINE TOPICAL- povidone-iodine solution
- NDC Code(s): 49348-622-37, 49348-622-38
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 19, 2023
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- Official Label (Printer Friendly)
- sunmark Povidone-Iodine 10% Topical Solution
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only.
Do not:
- use in the eyes.
- use longer than 1 week unless directed by a doctor.
- use on individuals who are allergic or sensitive to iodine.
- apply over large areas of the body.
- Directions
- Other Information
- Inactive Ingredients:
- PRINCIPAL DISPLAY PANEL
- sunmark Povidone-Iodine 10% Topical Solution 8oz (49348-622-37) | sunmark Povidone-Iodine 10% Topical Solution 16oz (49348-622-38)
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INGREDIENTS AND APPEARANCE
SUNMARK POVIDONE-IODINE TOPICAL
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-622 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 1 g in 100 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) NONOXYNOL-9 (UNII: 48Q180SH9T) SODIUM HYDROXIDE (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49348-622-37 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/15/2017 2 NDC:49348-622-38 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 12/15/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M003 06/28/2012 Labeler - Strategic Sourcing Services LLC (116956644) Registrant - Pharma Nobis, LLC (118564114) Establishment Name Address ID/FEI Business Operations Pharma Nobis, LLC 118564114 manufacture(49348-622) , analysis(49348-622) , pack(49348-622) , label(49348-622)