FULL CARE POVIDONE IODINE SWABSTICKS (POVIDONE-IODINE) SWAB [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]

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  • FULL CARE POVIDONE IODINE SWABSTICKS (POVIDONE-IODINE) SWAB [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]

FULL CARE POVIDONE IODINE SWABSTICKS (POVIDONE-IODINE) SWAB [SHAOXING FUQING HEALTH PRODUCTS CO., LTD.]
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NDC 65028-001-01, 65028-001-02
Set ID 38795a6b-106a-476f-a7cb-296ff5eb7fd9
Category HUMAN OTC DRUG LABEL
Packager Shaoxing Fuqing Health Products Co., Ltd.
Generic Name
Product Class
Product Number
Application Number PART333C
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  • ACTIVE INGREDIENT

    Active Ingredient: Povidone-Iodine USP (10%)

  • PURPOSE

    Purpose: Antiseptic

  • INDICATIONS & USAGE

    Use: Antiseptic skin preparation

  • WARNINGS

    Warnings:

    Do not use

    • if allergic to iodine
    • in the eyes

    For external use only

    Avoid "pooling" beneath patients.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek professional assistance or consult a poison control center immediately

  • ASK DOCTOR

    Ask a doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • redness, irritation, swelling, or pain persists or increases
    • infection occurs
  • DOSAGE & ADMINISTRATION

    Apply locally as need

  • OTHER SAFETY INFORMATION

    Other information

    • For hospital or professional use only
  • INACTIVE INGREDIENT

    Inactive Ingredient

    Citric Acid, Glycerin, Nonoxyol-10, Sodium Hydroxide, Water

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    FULL CARE POVIDONE IODINE SWABSTICKS 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65028-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.2 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65028-001-013 in 1 POUCH
    2NDC:65028-001-021 in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C04/22/2014
    Labeler - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Registrant - Shaoxing Fuqing Health Products Co., Ltd. (530545003)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shaoxing Fuqing Health Products Co., Ltd.530545003manufacture(65028-001)
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