Label: POVIDONE IODINE SCRUB- povidone iodine swab

  • NDC Code(s): 34645-1044-1
  • Packager: Jianerkang Medical Co., Ltd
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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  • Active Ingredients

    Povidone lodine USP,7.5% W/V (equivalent to 0.75% titratable iodine)

  • Purpose

    Antiseptic

  • Uses

    • Health-care antiseptic for preparation of the skin prior to surgery.
    • First aid antiseptic to help prevent the risk of skin infection in minor cuts,scrapes,and burns.
  • Warnings

    For external use only.

    • Do not use in the eyes
    • use on individuals who are allergic or sensitive to iodine
    • apply over large areas of the body use as a first aid antiseptic longer than 1 week unless directed by a doctor.
    • if irritation and redness develop. Consult a doctor in case of deep or puncture wounds animal bites serious burns. Discontinue use
  • Stop use and consult a doctor

    if the condition persists or gets worse.

  • Keep out of reach of children

    If swallowed, get medical help or contact Poison Control Center right away

  • Directions

    For preparation of the skin prior to surgery

    For use as a first aid antiseptic

    • clean the affected area
    • remove swab by stick
    • apply to the operative site prior to surgery. F
    • clean the affected area
    • apply a small amount of this product on the area 1-3 times daily
    • may be covered with a sterile bandage
    • if bandaged,let dry first.
  • Other information

    store at room temperature: 15°-30°C(59°-86°F)

  • Inactive Ingredients

    citric acid, distilled water, sodium hydroxide, alkyl polyglucoside nonylphenol ethoxylate

  • Package Label

    l1

  • INGREDIENTS AND APPEARANCE
    POVIDONE IODINE SCRUB 
    povidone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:34645-1044
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:34645-1044-13 in 1 POUCH06/11/2015
    145 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)06/11/2015
    Labeler - Jianerkang Medical Co., Ltd (530968767)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jianerkang Medical Co., Ltd530968767manufacture(34645-1044)