Label: LORIS POVIDONE-IODINE SOLUTION- povidone-iodine liquid

  • NDC Code(s): 68356-119-01, 68356-119-02, 68356-119-03, 68356-119-06, view more
    68356-119-07
  • Packager: LernaPharm Loris Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 21, 2023

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  • Active Ingredients

    Povidone Iodine 10% w/v

  • Purpose

    Antiseptic

  • Uses

    For preparation of the skin prior to surgery. Helps reduce bacteria that potentially can cause skin infection.

  • Warnings

    For External Use Only

    • Do not use in the eyes.
    • Discontinue use if irritation and redness develop.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Clean the area.
    • Apply product to the operative site prior to surgery.
    • Apply with friction for 30 seconds.
    • Do not blot or wipe away.
  • Other Information

    Store at room temperature between 59-86 oF (15-30 oC). 1% titratable iodine. Latex free

  • Inactive Ingredients

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

  • Questions or comments?

    Call 1-866-322-4634, weekdays between 8:00 am and 6:00 pm EST

  • Principal Display Panel

    Hold upright

    Product # 119-XXU NDC: 68356-119-XX

    Loris Povidone-Iodine [Solution]

    [TEAR OPEN] [Tear here and pour]

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

    [0.75 Fl. oz (22.5 mL)]

    Antiseptic Solution

    For hospital and professional use only

    MANUFACTURED BY

    LERNAPHARM (LORIS) INC.

    2323 HALPERN, VILLE ST-LAURENT

    QUEBEC, CANADA H4S 1S3

    image of 68356-119-01

    image of 68356-119-02

  • INGREDIENTS AND APPEARANCE
    LORIS POVIDONE-IODINE  SOLUTION
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68356-119
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68356-119-0222.5 mL in 1 POUCH; Type 0: Not a Combination Product04/16/2013
    2NDC:68356-119-062.6 mL in 1 PACKET; Type 0: Not a Combination Product07/14/201707/20/2022
    3NDC:68356-119-072.6 mL in 1 PACKET; Type 0: Not a Combination Product07/14/201707/20/2022
    4NDC:68356-119-013 in 1 POUCH04/16/2013
    42.5 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    5NDC:68356-119-031 in 1 POUCH07/14/201707/20/2022
    52.5 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)04/13/2013
    Labeler - LernaPharm Loris Inc. (206940905)
    Establishment
    NameAddressID/FEIBusiness Operations
    LernaPharm Loris Inc.206940905manufacture(68356-119) , label(68356-119) , pack(68356-119)
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