Label: APLICARE POVIDONE-IODINE SCRUB- povidone-iodine scrub solution

  • NDC Code(s): 52380-0024-1, 52380-0024-2, 52380-0024-3
  • Packager: Aplicare Products, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 15, 2022

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  • Active ingredient

    Povidone-iodine 10%

  • Purpose

    Antiseptic

  • Use

    Antiseptic skin preparation

  • Warnings

    For external use only

    Avoid pooling beneath the patient. Prolonged exposure to wet solution may cause skin irritation.

    Avoid excessive heat. Store at room temperature.

    Ask a doctor before use if injuries are

    • deep wounds
    • puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • redness, irritation, swelling or pain persists or increases
    • infection occurs

    Do not use

    • if allergic to iodine
    • in the eyes

    Keep out of reach of children.

    In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • Directions

    use sponges to prep desired area

  • Other information

    • for single use only
    • not made with natural rubber latex
    • for hospital or professiona use only
  • Questions or comments?

    800 633 5463

  • Inactive ingredients

    ammonium nonoxynol-4 sulfate, citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

  • Manufacturing Information

    Manufactured by:

    Aplicare Products, LLC

    550 Research Pkwy, Meriden, CT 06450 USA

    Made in USA with domestic and foreign materials

    1-800-633-5463

    REF: ORF22025S

    RD18APL

  • Package Label

    label

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE SCRUB 
    povidone-iodine scrub solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0024
    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
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    AMMONIUM NONOXYNOL-4 SULFATE (UNII: 9HIA70O4J0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0024-290 mL in 1 PACKET; Type 0: Not a Combination Product07/01/199202/28/2025
    2NDC:52380-0024-1120 mL in 1 PACKET; Type 0: Not a Combination Product07/01/199203/31/2025
    3NDC:52380-0024-3120 mL in 1 PACKET; Type 0: Not a Combination Product07/01/199201/31/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/199203/31/2025
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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