Label: DYNAREX POVIDONE IODINE PREP SOLUTION- povidone iodine prep solution liquid

  • NDC Code(s): 67777-141-30, 67777-141-31, 67777-141-40, 67777-141-41, view more
    67777-141-50, 67777-141-51, 67777-141-60, 67777-141-61
  • Packager: Dynarex Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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.

Drug Label Information

Updated December 1, 2022

If you are a consumer or patient please visit this version.

View All Sections
  • Active Ingredient

    Povidone-iodine 10%

  • Purpose

    Healthcare Antiseptic

  • Use

    For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection

  • Warnings

    For external use only

    Do Not Use

    • if allergic to iodine
    • in the eyes

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

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

  • Directions

    Clean the area. Apply product to the operative site prior to surgery.

  • Other

    Store at controlled room temperature.

  • Inactive Ingredients

    Citric Acid, Disodium Phosphate, Glycerin, Puried Water, Sodium Citrate, Tween 80

  • Questions?

    1-888-DYNAREX

  • Labeling

    1413 Label

  • INGREDIENTS AND APPEARANCE
    DYNAREX POVIDONE IODINE PREP SOLUTION 
    povidone iodine prep solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67777-141
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67777-141-3148 in 1 CASE05/08/2018
    1NDC:67777-141-30118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:67777-141-4124 in 1 CASE05/08/2018
    2NDC:67777-141-40237 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:67777-141-5124 in 1 CASE05/08/2018
    3NDC:67777-141-50473 mL in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:67777-141-614 in 1 CASE05/08/2018
    4NDC:67777-141-603790 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/08/2018
    Labeler - Dynarex Corporation (008124539)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!