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Iodine by Swabplus Inc.

Dosage form: solution
Ingredients: Povidone-Iodine 10mg in 1mL
Labeler: Swabplus Inc.
NDC Code: 65734-317

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.

Idoine Formula Filled Swab

Drug Facts

Active ingredient

Povidone Iodine 10%, equal to 1% available Iodine

Purpose

Antiseptic

Uses

First aid to help prevent infection due to minor cuts, scrapes and burns.

Keep out of reach of children

if swallowed, get medical help of contact a Poison Control Center right away.

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.

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

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.

Inactive ingredients

Glycerin, water

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.

Package and Labeling

Image of iodine carton  

IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-317
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (Iodine) Iodine10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Glycerin 
Sodium Hydroxide 
Product Characteristics
Colorbrown (dark) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65734-317-7272 APPLICATOR in 1 PACKAGE
1NDC:65734-317-000.15 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C03/01/2003
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc. (876441549)
Establishment
NameAddressID/FEIOperations
Swabplus Inc.876441549manufacture(65734-317), relabel(65734-317), repack(65734-317)

 
Swabplus Inc.

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Medically reviewed on Feb 16, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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