Label: IODINE- povidone-iodine solution
- 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.
Updated February 16, 2015
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- Drug Facts Active ingredient
Povidone Iodine 10%, equal to 1% available IodineClose
First aid to help prevent infection due to minor cuts, scrapes and burns.Close
- Keep out of reach of children
if swallowed, get medical help of contact a Poison Control Center right away.Close
- 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.
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 occursClose
For adulta and children 2 and older: for minor wounds, burns and infections, apply directly to affected area. May be covered with bandage.
Children under 2 years of ages: Do not use, consult a doctor.
Other information: Store at room temperature. Avoid direct sunlight, excessive heat and moisture.Close
- Inactive ingredients
- Manufacturer Statements
Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 USA Made in USA
The COLOR RING is copyrighted by Swabplus Inc.©2007 SWABPLUS INC.Close
- Package and Labeling
Image of iodine carton
- INGREDIENTS AND APPEARANCE
Product 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)