Label: SUNMARK POVIDONE-IODINE TOPICAL- povidone-iodine solution

  • NDC Code(s): 49348-622-37, 49348-622-38
  • Packager: Strategic Sourcing Services LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 19, 2023

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

View All Sections
  • sunmark Povidone-Iodine 10% Topical Solution


  • Active Ingredient

    Povidone Iodine 10%  (*Equivalent to 1% titratable Iodine)

  • Purpose

    Antiseptic

  • Uses

    First aid antiseptic to prevent infection in minor cuts, burns.

  • Warnings

    For external use only.

    Do not:

    • use in the eyes.
    • use longer than 1 week unless directed by a doctor.
    • use on individuals who are allergic or sensitive to iodine.
    • apply over large areas of the body.

    Stop use and consult a doctor if

    • condition persists or gets worse.
    • irritation and redness develop and persist for more than 72 hours.

    Ask a doctor in case of:

    • deep or puncture wounds
    • animal bites
    • serious burns.

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • Directions

    • Clean the affected area
    • Apply a small amount on the area 1 to 3 times daily.
    • May be covered with a sterile bandage.
    • If bandaged, let dry first.
  • Other Information

    Store at room temperature, 20-25 0 C (68-77 0 F).

  • Inactive Ingredients:

    Citric Acid, Disodium Phosphate, Glycerin, Nonoxynol-9, Sodium Hydroxide and Purified Water.

  • PRINCIPAL DISPLAY PANEL

    COMPARE TO BETADINE ACTIVE INGREDIENT*   sunmark povidone-iodine 10% Topical Solution  FIRST AID ANTISEPTIC  16 FL OZ (PT) 473mL  *This product is not manufactured or distributed by Purdue Frederick, owner of the registered trademark Betadine

  • sunmark Povidone-Iodine 10% Topical Solution 8oz (49348-622-37) | sunmark Povidone-Iodine 10% Topical Solution 16oz (49348-622-38)

    Povidone 8 ozPovidone 16 oz

  • INGREDIENTS AND APPEARANCE
    SUNMARK POVIDONE-IODINE TOPICAL 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-622
    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
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49348-622-37237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
    2NDC:49348-622-38473 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00306/28/2012
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - Pharma Nobis, LLC (118564114)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharma Nobis, LLC118564114manufacture(49348-622) , analysis(49348-622) , pack(49348-622) , label(49348-622)
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!