POVIDONE-IODINE PAD (POVIDONE-IODINE) SWAB [SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD. ]

POVIDONE-IODINE PAD (POVIDONE-IODINE) SWAB [SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD. ]
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NDC 42339-002-01, 42339-002-02
Set ID a1c21c1a-d316-4294-ba74-8d82c9092ee3
Category HUMAN OTC DRUG LABEL
Packager Shandong Haiyan Medical Manufacture Co., Ltd.
Generic Name
Product Class Antiseptic
Product Number
Application Number PART333C
  • Active Ingredient

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

    Purpose

    Antiseptic
  • Use

    Antiseptic for preparation of the skin.
  • Warnings

    For external use only.

    Discontinue use if irritation and redness develop.

    Keep out of reach of Children.
  • Directions


    Apply locally as needed.
    Other Information
    Store at room temperature: 59°- 86°F(15 - 30℃)
  • Inactive ingredients

    Purified Water
  • PRINCIPAL DISPLAY PANEL

    haiyan002
  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE PAD 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42339-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M) POVIDONE-IODINE9.43 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE (UNII: SE337SVY37)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42339-002-0110 in 1 CONTAINER
    1100 in 1 BOX
    10.6 g in 1 POUCH
    2NDC:42339-002-02100 in 1 CONTAINER
    2100 in 1 BOX
    20.6 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C02/18/2012
    Labeler - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shandong Haiyan Medical Manufacture Co., Ltd. 421283439manufacture

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