Label: POVIDONE-IODINE solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 15, 2024

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  • Active Ingredient

    Povidone Iodine 10% (available iodine 1%)

  • Purpose

    Topical antiseptic

  • Uses

    First aid topical antiseptic to help prevent infection in

    • minor cuts
    • scrapes
    • abrasions
  • Warnings

    For external use only.

    • do not get in eyes
  • ASK DOCTOR

    Ask a dcotor before use if you have

    • deep or puncture wounds
    • serious burns
  • STOP USE

    Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs
  • DO NOT USE

    Do not use

    • on animal bits
    • in or near the eyes or over large portions of the body
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help immediately or contact a Poison Control Center right away. 1-800-222-1222

  • Directions

    Adults and children 12 years of age and older:

    • reverse cardboard sleeve
    • crush at dot between thumb and forefinger to release fluid
    • gently wipes injured area to clean and disinfect
    • dispose of swab peoperly
    • do not reuse swab

    Children under 12 years of age: ask a doctor

  • Other information

     Store at room temperaturem 59° - 86°F (15° - 30°C) away from light. Keep from freezing or excessive heat.

  • Inactive ingredients

    citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water.

  • Packaging

    PVPswabv24f.jpgPVPswabv24f.jpg

  • INGREDIENTS AND APPEARANCE
    POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50332-0056
    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)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50332-0056-110 in 1 BOX, UNIT-DOSE01/01/1980
    10.6 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00301/01/1980
    Labeler - HART Health (069560969)
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