Label: SWABSTICKS TRIPLE PACK- povidone-iodine swab
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Contains inactivated NDC Code(s)
NDC Code(s): 53329-942-02 - Packager: Medline Industries, 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 February 19, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
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- in the eyes
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- Longer than one week unless directed by a doctor
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- On individuals who are allergic or sensitive to iodine
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- Or apply over large areas of the body
- Directions
- Other information
- Inactive ingredients
- Questions?
- Package Label - Box Principal Display Panel top
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INGREDIENTS AND APPEARANCE
SWABSTICKS TRIPLE PACK
povidone-iodine swabProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53329-942 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 100 mg Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) GLYCERIN (UNII: PDC6A3C0OX) NONOXYNOL-10 (UNII: K7O76887AP) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53329-942-02 3 in 1 POUCH 1 10 mg in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333E 11/26/2014 Labeler - Medline Industries, Inc. (025460908)