Label: PARA-AID POVIDONE-IODINE PREP PADS- povidone iodine irrigant

  • 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 October 28, 2019

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

View All Sections
  • Active Ingredient

    Povidone Iodine 10%

  • Uses

    For preparation of the skin prior to surgery

  • Warnings

    For External Use Only

    Flammable, keep away from fire or fame.

  • Do not use

    in the eyes

  • Stop use

    if irritation and redness develops

    if condition persists for more than 72 hours, consult a physician

  • Keep out of reach of children

    if swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    Wipe surgery site vigorously and discard.

  • Other information

    Store at room temperature 15°-30°C (59°-86°F)

  • Inactive ingredients

    Nonoxynol-9, water

  • DOSAGE & ADMINISTRATION

    Sterile unless pouch is opened or damaged.

    Saturated with 10% Povidone Iodine.

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    First aid to help prevent infection in minor cuts, scrapes, and burns

  • Package.Label Principal Display Panel

    Povidone-Iodine Prep Pad

    1 Pad

    Medium

    img_2af85fb9-7b8d-57d6-e054-00144ff88e88

  • INGREDIENTS AND APPEARANCE
    PARA-AID POVIDONE-IODINE PREP PADS 
    povidone iodine irrigant
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52486-001
    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
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52486-001-0110 mL in 1 PACKET; Type 0: Not a Combination Product02/04/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/02/2016
    Labeler - Mcure Health Solutions Inc. (053034873)
    Registrant - Mcure Health Solutions Inc. (053034873)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taizhou Kangping Medical Science And Technology Co., Ltd543429840manufacture(52486-001)
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!