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 5, 2019

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

  • ACTIVE INGREDIENT

    Povidone-iodine

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    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 DOCTOR

    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

    Do not use

    • if allergic to iodine

    • in the eyes

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions

    use sponges to prep desired area

  • OTHER SAFETY INFORMATION

    Other information

    • for single use only

    • not made with natural rubber latex

    • for hospital or professiona use only

  • QUESTIONS

    For questions or comments

    800 633 5463

  • INACTIVE INGREDIENT

    Inactive ingredients

    • ammonium nonoxynol-4 sulfate

    • citric acid

    • disodium phosphate

    • nonoxynol-9

    • sodium hydroxide

    • water

  • PRINCIPAL DISPLAY PANEL

    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 Product07/01/1992
    2NDC:52380-0024-1120 mL in 1 PACKET; Type 0: Not a Combination Product07/01/1992
    3NDC:52380-0024-3120 mL in 1 PACKET; Type 0: Not a Combination Product07/01/1992
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/1992
    Labeler - Aplicare Products, LLC. (081054904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare Products, LLC081054904manufacture(52380-0024)