POVIDONE-IODINE PREP PAD (POVIDONE-IODINE) SWAB [NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ]

POVIDONE-IODINE PREP PAD (POVIDONE-IODINE) SWAB [NANTONG STRIP MEDICAL SUPPLY CO.,LTD. ]
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NDC 35617-392-81
Set ID cd8a3db6-be3f-4106-9aec-cb2147c828f2
Category HUMAN OTC DRUG LABEL
Packager NANTONG STRIP MEDICAL SUPPLY CO.,LTD.
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333C
  • 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
    If swallowed,get medical help or contact a Poison Control Center right away.
  • Directions

    Apple locally as needed.

  • Other information

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

    Use

    Antiseptic for preparation of the skin
  • Inactive Ingredients

    Water,Citric acid,  Disodium phosphate, Nonoxynol-9, Sodium Hydroxide,Purified Water
  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PREP PAD 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:35617-392
    Route of AdministrationPERCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 89.96 mL
    Citric acid (UNII: 2968PHW8QP) 0.01 mL
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T) 0.01 mL
    NONOXYNOL-9 (UNII: 48Q180SH9T) 0.01 mL
    Sodium Hydroxide (UNII: 55X04QC32I) 0.01 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:35617-392-81100 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C05/17/2010
    Labeler - NANTONG STRIP MEDICAL SUPPLY CO.,LTD. (546585519)
    Establishment
    NameAddressID/FEIBusiness Operations
    NANTONG STRIP MEDICAL SUPPLY CO.,LTD. 546585519manufacture

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