Label: POVIDONE-IODINE PREP PAD- povidone-iodine swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 February 1, 2018

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

  • Active Ingredient

    POVIDONE-IODINE 10% W/v (equivalent to iodine 1%)

    Purpose

    Antiseptic

  • Warnings

    For External use only.
    Discontinue use if irritation and redness develop

    Keep out of reach of children

    Keep out of reach of children

  • Directions

    Apple locally as needed.

  • Other information

    Store at room temperature:59o-86oF(15--30℃)

    Use

    Antiseptic for preparation of the skin

  • Inactive Ingredients

    Purified Water

  • PRINCIPAL DISPLAY PANEL

    002

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PREP PAD 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72059-002
    Route of AdministrationPERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72059-002-011 in 1 PACKAGE; Type 0: Not a Combination Product02/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/01/2018
    Labeler - Nantong Sirius Packing Products Co., Ltd. (546071515)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nantong Sirius Packing Products Co., Ltd.546071515manufacture(72059-002)