Label: APLICARE POVIDONE-IODINE- povidone-iodine solution

  • NDC Code(s): 52380-1721-1
  • 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 USP 10%

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    • antiseptic skin preparation

    • single use when used for patient preoperative skin preparation and/or preinjection indication

  • 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.

  • WARNINGS

    For external use only.

    Do not use

    • in the eye
    • on individuals allergic or sensitive to iodine

    Ask doctor before use if injuries are

    • deep or puncture wounds
    • serious burns

    Stop use and ask a doctor if

    • infection occurs

    • redness, irritation, swelling or pain persists or increases

    Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    • Reverse cardboard sleeve then crush at dot between thumb and forefinger
    • Allow solution to saturate tip
    • apply topically as needed
  • INACTIVE INGREDIENT

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

  • OTHER SAFETY INFORMATION

    Other information

    • Not made with natural rubber latex

    • for hospital or professional use only

  • QUESTIONS

    Questions or comments?

    1 800 633 5463

  • PRINCIPAL DISPLAY PANEL

    APLICARE

    POVIDONE-IODINE PREP SWABS

    ANTISEPTIC

    NON-STERILE SOLUTION

    Label BoxLabel Each

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-1721
    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
    NONOXYNOL-10 (UNII: K7O76887AP)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-1721-10.65 mL in 1 PACKET; Type 0: Not a Combination Product09/01/199811/06/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/01/199811/06/2022
    Labeler - Aplicare Products, LLC. (081054904)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aplicare Products, LLC.081054904manufacture(52380-1721)