Label: APLICARE- povidone iodine swab

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 27, 2024

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  • Active ingredient

    Povidone-iodine USP 10% w/w

  • Purpose

    Antiseptic

  • Uses

    • antiseptic skin preparation
    • first aid to help prevent infection in minor cuts, scrapes, and burns
  • Warnings

    Do not use

    • if allergic to iodine
    • in the eyes
    • or apply over large areas of the body
    • longer than 1 week unless directed by a doctor

    For external use only

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours or gets worse
    • in case of deep or puncture wounds, animal bites, or serious burns

    Avoid pooling beneath patient

    Keep out of reach of children.

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

  • Directions

    • clean the affected area
    • for first aid antiseptic: apply a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first
  • Other information

    • 1% titratable iodine
    • not made with natural rubber latex
    • for hospital or professional use only
    • for single use only
    • protect from freezing, avoid excessive heat
  • Inactive ingredients

    citric acid, disodium phosphate, purified water

  • Manufacturer 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. Made in China. 1-800-MEDLINE.
    V1 RI24LPD

  • Package label

    label

  • INGREDIENTS AND APPEARANCE
    APLICARE 
    povidone iodine swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0946
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0946-33 in 1 PACKET09/27/2024
    12 g 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)09/27/2024
    Labeler - Aplicare Products LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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