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POVIDONE-IODINE by James Alexander Corporation

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: James Alexander Corporation
NDC Code: 46414-7777

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Active Ingredients (each swab)

10% povidone Iodine solution USP

Purpose 1% available iodine topical antiseptic

Uses to treat minor skin cuts and abrasions

Warnings for external use only

Ask a doctor before use if you have deep or punction wounds seiour burns stop use and ask a doctor if redness irration swelling or pain persists or increases infection occurs

Keep out of reach of children.  If swallowed get medical help immediately or contact a Poison Control Center right away

Directions reverse cardboard sleeve then crush at dot between thumb and forefinger.  allow solution to saturate tip and apply solution to injury

Other information Store at room temperature away from light.  Keep from freezing or excessive heat.

Inactive Ingredients citric acid, disodium phosphate, nonoxynol 9 sodium hydroxide water

Questions ? Call 1-908-362-9266 monday through friday, 9:00am to 5:00pm e.s.t.

Active Ingredients (each swab) 10% povidone Iodine solution USP

Purpose (1% available iodine) topical antiseptic

Uses to treat minor skin cuts and abrasions

Warnings for external use only

Ask a doctor before use if you have deep or puncture wounds serious burns stop use and ask a doctor if redness irritation swelling or pain persists or increases infection occurs

Keep out of reach of children.  If swallowed get medical help immediately or contact a Poison Control Center right away.

Directions reverse cardboard sleeve then crush at dot between thumb and forefinger.  Allow solution to saturate tip and apply solution to injury

Other Information store at room temperature away from light.  Keep from freezing or excessive heat.

Inactive Ingredients Citric Acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

Questions ? Call 1-908-363-9266 Monday through Friday, 9:00am to 5:00pm e.s.t.

Reorder No 771 100 swabs Povidone Iodine Topical Solution USP 0.02 fl. oz. (0.6 ml) each dispensing solutions

James Alexander Corportion

Blairstown, NJ 908-362-9266 Product Information and MSDS available online at www.james-alexander.com

ANSI Z308.1-2003 Reorder No. 773

Povidone Iodine Topical Solution USP Swabs 10 swabs 0.02 fl. oz. (0.6 ml) each dispensing solutions

James Alexander Corporation Blairstown, NJ 908-362-9266 Product Information and MSDS availabel online at www.james-alexander.com

POVIDONE-IODINE 
povidone-iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:46414-7777
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
citric acid monohydrate 
phosphate ion 
nonoxynol-9 
sodium hydroxide 
water 
Packaging
#Item CodePackage Description
1NDC:46414-7777-310 VIAL, SINGLE-USE in 1 CONTAINER
10.6 mL in 1 VIAL, SINGLE-USE
2NDC:46414-7777-2100 VIAL, SINGLE-USE in 1 CONTAINER
20.6 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/14/1976
Labeler - James Alexander Corporation (040756421)
Registrant - James Alexander Corporation (040756421)
Establishment
NameAddressID/FEIOperations
James Alexander Corporation040756421manufacture(46414-7777)

Revised: 06/2014
 
James Alexander Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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