Label: BETADINE- 10% povidone-iodine liquid

  • NDC Code(s): 0116-0150-01, 0116-0150-04, 0116-0150-05, 0116-0150-09, view more
    0116-0150-17
  • Packager: Xttrium Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2024

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  • Active Ingredient

    Povidone-iodine, 10%

  • Purpose

    Antiseptic

  • Uses

    Patient pre-operative skin preparation
    ■ 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 ■ if you are allergic to povidone-iodine or any
    other ingredients in this preparation
    When using this product
    ■ prolonge exposure to wet solution may cause irritation or, rarely severe skin
    reactions ■ in pre-operative prepping, avoid "pooling" beneath the patient
    Stop use and ask a doctor if
    ■ irritation, sensitization, or allergic reaction occurs and lasts for 72 hours.
    These may be signs of a serious condition.

    Keep out of reach of children

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

  • Directions

    ■ single use only ■ clean the operative site prior to surgery
    ■ apply product and allow to dry ■ may be covered with a sterile bandage

  • Other information

    ■ store in original container

    ■ store at 25'C (77'F); excursions permitted between 15'-30'C (59'-86'F)

  • Inactive Ingredient

    citric acid, disodium phosphate, glycerin, nonoxynol-9, purified water, sodium hydroxide

  • Questions?

    1-833-288-2684

  • PRINCIPAL DISPLAY PANEL

    10% Professional .5oz10% Professional 4oz

    10% Professional 8oz10% Betadine 16oz10% Betadine 1 gallon

  • INGREDIENTS AND APPEARANCE
    BETADINE 
    10% povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-0150-0514.8 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
    2NDC:0116-0150-013780 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
    3NDC:0116-0150-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
    4NDC:0116-0150-09237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
    5NDC:0116-0150-17473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00311/05/2024
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories007470579manufacture(0116-0150)
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