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povidine iodine by Dynarex Corporation

Dosage form: swab
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Dynarex Corporation
NDC Code: 67777-419

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.

Povidone Iodine Swabstick

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Active Ingredient                                                        Purpose

Povidone Iodine 10% w/v (9.85% w/w/)                        Antiseptic                          

Purpose:


Purpose:

  • First aid antiseptic to help prevent skin infection in minor cuts, scrapes and burns.
  • For preparation of the skin prior to surgery.
  • Helps reduce bacteria that can potentially cause skin infections.

Warnings:

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  • FOR EXTERNAL USE ONLY

Do not use:
  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Ask a doctor before use if you have:


  • Deep puncture wounds
  • Animal bites
  • Serious burns

Stop Use:


  • If irritation and redness develop
  • If condition persists for more than 72 hours, consult a physician.

Keep Out Of Reach Of Children

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


Directions Povidone iodine:

Tear at notch, remove applicator, use only once.

As a first aid antiseptic

  • clean affected area
  • apply 1 to 3 times daily
  • may be covered with a sterile bandage, if bandaged let dry.

For preoperative patient skin preparation

  • clean area
  • apply to operative site prior to surgery using the applicator


Other information:

Store at room temperature.

Avoid excessive heat

For use as an

  • first aid antiseptic
  • pre-operative skin preperation

Inactive Ingredients

Inactive ingredients: Citric acid, glycerin, polysorbate 80, sodium citrate USP, sodium phosphate dibasic, water

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Principal Display Panel

Povidone Iodine Swabsticks 1201 & 1202

PVP 419.jpg

POVIDINE IODINE 
povidine iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-419
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 ACETATE 
GLYCERIN 
POLYSORBATE 80 
SODIUM CITRATE 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
water 
Packaging
#Item CodePackage Description
1NDC:67777-419-010.3 mL in 1 PACKET
2NDC:67777-419-020.9 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/13/2016
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Sion Biotext Medical Ltd532775194manufacture(67777-419)

Revised: 09/2016
 
Dynarex 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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