Label: APLICARE- povidone-iodine swab

  • NDC Code(s): 52380-0138-1, 52380-0138-2
  • Packager: Aplicare Products LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 6, 2024

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  • Active ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Use

    helps reduce bacteria that potentially can cause skin infection

  • Warnings

    For external use only

    Do not use

    • if allergic to iodine
    • in the eyes

    Stop use and ask a doctor if

    • redness, irritation, swelling or pain develops or persists for more than 72 hours
    • infection occurs

    Keep out of reach of children.

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

  • Directions

    apply locally as needed

  • Other information

    • 1% w/w titratable iodine
    • not made with natural rubber latex
    • for hospital or professional use only
    • protect from freezing, avoid excessive heat
    • store at room temperature
  • Inactive ingredients

    disodium phosphate, dodecamethylpentasiloxane, glycerol, hydroxyethylcellulose, nonylphenoxypoly (ethyleneoxy) ethanol-10, water

  • Manufacturing information

    www.medline.com

    ©2024 Medline Industries, LP

    Aplicare is a registered trademark of Medline Industries, LP.

    Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA

    1-800-MEDLINE.

    Made in China. V1 RH24JJS

  • Package label

    labellabel

  • INGREDIENTS AND APPEARANCE
    APLICARE 
    povidone-iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0138
    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
    DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    WATER (UNII: 059QF0KO0R)  
    NONOXYNOL-2 (UNII: U4A966MO25)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0138-11 in 1 POUCH09/01/2024
    12.4 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:52380-0138-250 in 1 BOX09/01/2024
    21 in 1 POUCH
    22.4 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)09/01/2024
    Labeler - Aplicare Products LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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