POVIDONE-IODINE SWAB [NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ]

POVIDONE-IODINE SWAB [NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ]
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NDC 35617-397-01
Set ID 117aa16f-f83d-44dd-9c03-c141f6283c1f
Category HUMAN OTC DRUG LABEL
Packager NANTONG STRIP MEDICAL SUPPLY CO.,LTD.
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333E
  • 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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