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povidine iodine by Dynarex Corporation

Medically reviewed on February 12, 2018

Dosage form: swab
Ingredients: POVIDONE-IODINE 10mL in 100mL
Labeler: Dynarex Corporation
NDC Code: 67777-301

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 Gel Swabstick

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Uses:


  • 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:


  • 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 Gel Swabstick:

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:

Sterile

Store at room temperature.

Avoid excessive heat

For use as an

  • first aid antiseptic
  • pre-operative skin preperation

Inactive Ingredients

Inactive ingredients: citric acid, glycerol, nonoxynol-10, sodium hydroxide, water

Principal Display Panel

PVP_Gel_Swabstick

POVIDINE IODINE 
povidine iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-301
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (POVIDONE-IODINE) POVIDONE-IODINE10 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
NONOXYNOL-10 
CITRIC ACID MONOHYDRATE 
WATER 
GLYCERIN 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:67777-301-0110 BOX (BOX) in 1 CASE
150 POUCH (POUCH) in 1 BOX
11 POUCH (STICK) in 1 POUCH
1.3 mL in 1 POUCH
2NDC:67777-301-0210 BOX (BOX) in 1 CASE
225 POUCH (POUCH) in 1 BOX
23 POUCH (STICK) in 1 POUCH
2.9 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/10/2012
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

 
Dynarex Corporation

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Further information

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

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