Label: POVIDONE-IODINE swab

  • 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 July 5, 2011

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  • Use

    Antiseptic for preparation of skin.

    Purpose

    Antiseptic
  • Cautions

    For External Use Only.
    Do not use:
    Apply over large areas of the body, use in the eyes
    Drug Facts (continued):
    Stop use and ask a doctor 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 injection site vigorously and discard.
  • Other information

    Store at room temperature, 59º-86ºF(15º-30℃), avoid excessive heat.
  • Active Ingredient

    Povidone Iodine 10% w/v (equivalent to 1%iodine)

    Inactive Ingredients

    Water
  • PRINCIPAL DISPLAY PANEL

    Enter section text here397

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35617-397
    Route of AdministrationPERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE0.1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.9 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35617-397-011 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/20/2011
    Labeler - NANTONG STRIP MEDICAL SUPPLY CO.,LTD. (546585519)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANTONG STRIP MEDICAL SUPPLY CO.,LTD. 546585519manufacture
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