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povidine iodine by Dynarex Corporation

Medically reviewed on September 13, 2018

Dosage form: swab
Ingredients: POVIDONE-IODINE 10g in 100g
Labeler: Dynarex Corporation
NDC Code: 67777-420

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 Prep Pad

Section Text

Active Ingredient                                                      Purpose

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

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.

Do not use:

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  • As a first aid antiseptic for more than 1 week.
  • In the eyes.
  • Over large areas of the body.

Warnings

FOR EXTERNAL USE ONLY

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:

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


Usage
  • As a first aid antiseptic and preparation of skin prior to surgery.

Other information:

Store at room temperature.

Avoid excessive heat

Inactive ingredients

Citric acid, glycerin, poysorbate 80, sodium citrate USP, sodium phosphate dibasic, water

Principal Display Panel

Principal Display Panel

POVIDINE IODINE 
povidine iodine swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-420
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID ACETATE 
GLYCERIN 
POLYSORBATE 80 
SODIUM CITRATE 
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 
water 
Packaging
#Item CodePackage Description
1NDC:67777-420-01.3 g in 1 POUCH
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(67777-420)

 
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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