ISODINE COPITOS - povidone-iodine  solution 
Swabplus Inc.

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.

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Isodine Copitos

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

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

Glycerin, water

Manufacturer Statement

Patented and manufactured by Swabplus Inc. Rancho Cucamonga, CA 91730 USA Made in USA

Imported and Distributed by Boehringer Ingelheim

Package and Labeling

Image of iodine carton label

Image of iodine carton label

ISODINE COPITOS  
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65734-511
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Povidone-Iodine (UNII: 85H0HZU99M) (Iodine - UNII:9679TC07X4) Iodine10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Sodium Hydroxide (UNII: 55X04QC32I)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
Colorbrown (dark) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65734-511-7272 in 1 PACKAGE
1NDC:65734-511-000.15 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C06/01/2008
Labeler - Swabplus Inc. (876441549)
Registrant - Swabplus Inc. (876441549)
Establishment
NameAddressID/FEIBusiness Operations
Swabplus Inc.876441549manufacture(65734-511) , relabel(65734-511) , repack(65734-511)

Revised: 2/2015
Document Id: 4edad3eb-85be-41d6-8965-1859bddc3576
Set id: 8629d5dd-2a59-4184-89e5-d63b77e66226
Version: 2
Effective Time: 20150216
 
Swabplus Inc.