Label: IODINE- povidone-iodine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 65734-317-00, 65734-317-72 - Packager: Swabplus Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 16, 2015
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts Active ingredient
- Purpose
- Keep out of reach of children
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Directions
- Hold the swab vertically, with the color ring tip upwards. Hold in the center of the tube with one hand at the color ring with the other.
- Gently snap the tip with the color ring. Formula inside the tube flows down and fills the opposite tip.
- Apply the product to the affected area.
- Discard swab after use.
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Warnings
For external use only. Keep out of eyes and ear canal. Non-Sterile. Discontinue use if irritation occurs.
Do not use. if you are sensitive to Iodine. longer than one week unless directed by a doctor.
Stop use and ask a doctor if. you have deep or puncture wounds, or serious burns. redness, irritation, swelling or pain continues or increases. infection occurs
- Administration
- Inactive ingredients
- Manufacturer Statements
- Package and Labeling
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INGREDIENTS AND APPEARANCE
IODINE
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65734-317 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 Water (UNII: 059QF0KO0R) Glycerin (UNII: PDC6A3C0OX) Sodium Hydroxide (UNII: 55X04QC32I) Product Characteristics Color brown (dark) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65734-317-72 72 in 1 PACKAGE 1 NDC:65734-317-00 0.15 mL in 1 APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 03/01/2003 Labeler - Swabplus Inc. (876441549) Registrant - Swabplus Inc. (876441549) Establishment Name Address ID/FEI Business Operations Swabplus Inc. 876441549 manufacture(65734-317) , relabel(65734-317) , repack(65734-317)