Label: EASY TO BREAK-OFF CLEANING AND DISINFECTING SWABSTICK DFB-I- povidone iodine swabstick swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 6, 2020

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  • Active Ingredient

    Povidone Iodine 10%

  • Dosage

    SWAB

  • Purpose

    First Aid Antiseptic

  • Use

    First aid to help prevent infection in minor cuts, scrapes, and burns

  • Warning

    For external use only.

  • Do Not Use

    ● use in the eyes

    ●apply over large areas of the body

    ● use on individuals who are allergic or sensitive to iodine

  • Stop Use and Consult a Doctor

    ●if the condition persists or gets worse

    ● for use longer than 1 week. Ask a doctor in case of deep or puncture wounds, animal bites, serious burns

  • Keep out of reach of children

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

  • Inactive Ingredient 

    Nonoxynol-10, Purified water

  • Image of Pouch Label

    Image of Pouch Label

  • INGREDIENTS AND APPEARANCE
    EASY TO BREAK-OFF CLEANING AND DISINFECTING SWABSTICK DFB-I 
    povidone iodine swabstick swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62382-0322
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE0.1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-10 (UNII: K7O76887AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62382-0322-10.2 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)03/28/2014
    2NDC:62382-0322-20.3 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)03/28/2014
    3NDC:62382-0322-30.4 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)03/28/2014
    4NDC:62382-0322-40.5 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)03/28/2014
    5NDC:62382-0322-50.6 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)03/28/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/28/2014
    Labeler - Longood Medicine (Beijing) Co., Ltd. (529553064)
    Establishment
    NameAddressID/FEIBusiness Operations
    Longood Medicine (Beijing) Co., Ltd.529553064manufacture(62382-0322)
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