Label: SANINTA 10% POVIDONE-IODINE- povidone-iodine solution liquid

  • NDC Code(s): 68356-601-01, 68356-601-02, 68356-601-03
  • Packager: Lernapharm
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 15, 2024

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  • Active Ingredient

    Povidone-Iodine 10% w/v

  • Purpose

    Antiseptic

  • Use

    Antiseptic skin preparation. Helps reduce bacteria that potentially can cause skin infection.

  • Warnings

    For external use only.

    Do not use

    Do not use

    • if allergic to iodine
    • in the eyes

    Stop use and ask a doctor

    Stop use and ask a doctorif

    • injuries are deep puncture wounds or serious burns
    • redness, irritation, swelling or pain persists or increases
    • infection occurs

    Avoid pooling beneath patient

    Avoid pooling beneath patient

    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

    • Clean the area.
    • apply locally as needed
  • Other Information

    • 1% titratable iodine
    • not made with natural rubber latex
    • for hospital or professional use only
    • Store at room temperature between 59-86ºF (15 - 30ºC).
    • Avoid freezing and excessive heat above 40ºC (104ºF).
  • Inactive ingredients

    Citric Acid, Glycerol, Nonoxynol-9, Purified Water USP, Sodium Hydroxide, Sodium Phosphate Dibasic

  • Questions or Comments?

    Questions or Comments? Tel.: 1-866-322-4634, weekdays between 8:00 am and 4:00 pm EST

  • Package Label - Principal Display Panel

    NDC: 68356-601-01 / 68356-601-601-02 / 68356-601-03

    Product # 601-01 / 601-02 / 601-03

    Hold upright

    [Tear here and pour]

    [Three 4-inch antiseptic swabsticks impregnated with 10% W/V povidone-iodine solution]

    [Tear open]

    Saninta

    Antiseptic Solution

    10% w/v Povidone-Iodine Solution

    10% Povidone-Iodine

    [0.75 Fl. oz (22.5 mL)]

    [0.5 Fl. oz (15 mL)]

    Do Not Reuse

    multiple-use cross-through logo

    UPC Code

    Manufactured by:

    Lernapharm (LORIS) Inc.

    2323 HALPERN, MONTREAL

    QUEBEC, CANADA H4S 1S3

    Made in Canada

    LOT #: XXXX

    EXP.: MM/YYYY

    image of 68356-601-01 label

    image of 68356-601-02

    image of 68356-601-03 label

  • INGREDIENTS AND APPEARANCE
    SANINTA 10% POVIDONE-IODINE 
    povidone-iodine solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68356-601
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68356-601-013 in 1 POUCH02/26/2024
    12.3 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:68356-601-0222.5 mL in 1 PACKET; Type 0: Not a Combination Product02/26/2024
    3NDC:68356-601-0315 mL in 1 PACKET; Type 0: Not a Combination Product11/14/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)02/26/2024
    Labeler - Lernapharm (206940905)
    Registrant - Lernapharm (206940905)
    Establishment
    NameAddressID/FEIBusiness Operations
    Lernapharm206940905manufacture(68356-601) , analysis(68356-601) , label(68356-601) , pack(68356-601)
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