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povidone iodine by Dynarex Corporation

Medically reviewed on January 8, 2018

Dosage form: solution
Ingredients: POVIDONE-IODINE 10mg in 1mL
Labeler: Dynarex Corporation
NDC Code: 67777-100

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

Active Ingredient                                  Purpose

Povidone Iodine 10% v/v                        Antiseptic                          

Purpose

Purpose of povidone iodine prep

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.

Inactive Ingredient

Inactive Ingredient: Citric Acid, Glycerin, Sodium Citrate, Tween 80, Disodium Phosphate, Water

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:


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


For use as an

  • first aid antiseptic
  • pre-operative skin preperation

Principal Display Panel

povidone_iodine_prep

POVIDONE IODINE 
povidine iodine solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-100
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 
WATER 
GLYCERIN 
SODIUM CITRATE 
POLYSORBATE 80 
SODIUM PHOSPHATE 
Packaging
#Item CodePackage Description
1NDC:67777-100-0648 BOTTLE (BOTTLE) in 1 CASE
159 mL in 1 BOTTLE
2NDC:67777-100-0148 BOTTLE (BOTTLE) in 1 CASE
2118 mL in 1 BOTTLE
3NDC:67777-100-0224 BOTTLE (BOTTLE) in 1 CASE
3237 mL in 1 BOTTLE
4NDC:67777-100-0324 BOTTLE (BOTTLE) in 1 CASE
4474 mL in 1 BOTTLE
5NDC:67777-100-0412 BOTTLE (BOTTLE) in 1 CASE
5946 mL in 1 BOTTLE
6NDC:67777-100-054 BOTTLE (BOTTLE) in 1 CASE
63784 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/03/2002
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIOperations
Degasa, S.A. de C.V.812771980manufacture(67777-100)

 
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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