Label: BETADINE- povidone-iodine liquid

  • NDC Code(s): 0116-0160-03
  • Packager: Xttrium Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 7, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Povidone-iodine, 5%

  • PURPOSE

    First aid antiseptic

  • INDICATIONS & USAGE

    first aid to help prevent infection in minor
    ■ cuts ■ scrapes ■ burns

  • WARNINGS

    Warnings For external use only
    Do not use ■ in the eyes ■ over large areas of the body ■ if you are
    allergic to povidone-iodine or any other ingredients in this preparation
    Ask a doctor before use if you have ■ deep or puncture wounds
    ■ serious burns ■ animal bites
    Stop use and ask a doctor if ■ the condition persists or gets worse
    ■ you need to use this product for more than 1 week

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

  • DOSAGE & ADMINISTRATION

    ■ clean the affected area
    ■ spray a small amount
    of product on the area 1 to 3 times daily
    ■ may be covered with a sterile bandage
    ■ if bandaged, let dry first

  • OTHER SAFETY INFORMATION

    ■ store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Do Not Freeze

  • INACTIVE INGREDIENT

    pareth 25-9, purified water, sodium hydroxide

  • QUESTIONS

    1-833-288-2684

  • PRINCIPAL DISPLAY PANEL

    Betadine 3oz Spray

  • INGREDIENTS AND APPEARANCE
    BETADINE 
    povidone-iodine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0160
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C12-15 PARETH-9 (UNII: H3ZIY6WP1R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0116-0160-0388.7 mL in 1 BOTTLE; Type 0: Not a Combination Product11/07/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00311/07/2024
    Labeler - Xttrium Laboratories, Inc. (007470579)
    Registrant - Xttrium Laboratories, Inc. (007470579)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xttrium Laboratories, Inc.007470579manufacture(0116-0160)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!