Label: ISODINE COPITOS- povidone-iodine solution
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Contains inactivated NDC Code(s)
NDC Code(s): 65734-511-00, 65734-511-72 - 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
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug FactsActive ingredient
- Purpose
- Keep out of reach of children
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Directions
- Hold the swab vertically, with the color ring tip upwards, Hold n 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.
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 continue or increas., infedtion occurs. -
Administration
For adults and children 2 and older: for minor wounds, burns and infections, apply directly to affected area. May be covered with a bandage.
Children under 2 years of age: Do not use, consult a doctor.
Other information: Store art room temperature, Avoid direct sunlight, excessive heat and moisture. - Inactive ingredients
- Manufacturer Statement
- Package and Labeling
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INGREDIENTS AND APPEARANCE
ISODINE COPITOS
povidone-iodine solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65734-511 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 Glycerin (UNII: PDC6A3C0OX) Sodium Hydroxide (UNII: 55X04QC32I) WATER (UNII: 059QF0KO0R) 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:65734-511-72 72 in 1 PACKAGE 1 NDC:65734-511-00 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 06/01/2008 Labeler - Swabplus Inc. (876441549) Registrant - Swabplus Inc. (876441549) Establishment Name Address ID/FEI Business Operations Swabplus Inc. 876441549 manufacture(65734-511) , relabel(65734-511) , repack(65734-511)
