Label: POVIDONE-IODINE SWABSTICKS SINGLES- povidone-iodine swab
POVIDONE-IODINE SWABSTICKS TRIPLES- povidone-iodine swab
- NDC Code(s): 53329-945-09, 53329-945-29, 53329-946-02, 53329-946-75
- Packager: Medline Industries, LP
- 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 September 28, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
-
Warnings
For external use only
Do not use
- in the eyes
- longer than one week unless directed by a doctor
- on individuals who are allergic or sensitive to iodine
- or apply over large areas of the body
- Directions
- Other information
- Inactive ingredients
- Manufacturing Information
- Package Label
- Tiple Swab Package Label
-
INGREDIENTS AND APPEARANCE
POVIDONE-IODINE SWABSTICKS SINGLES
povidone-iodine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-945 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-945-29 50 in 1 BOX 12/12/2018 1 1 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:53329-945-09 1 mL in 1 PACKET; Type 0: Not a Combination Product 01/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/01/2007 POVIDONE-IODINE SWABSTICKS TRIPLES
povidone-iodine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-946 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 CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) WATER (UNII: 059QF0KO0R) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-946-75 25 in 1 BOX 12/12/2018 1 NDC:53329-946-02 3 mL in 1 PACKET; Type 0: Not a Combination Product 2 NDC:53329-946-02 3 mL in 1 PACKET; Type 0: Not a Combination Product 01/01/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 01/01/2007 Labeler - Medline Industries, LP (025460908) Registrant - Medline Industries, LP (025460908)