Label: MEDIPLAST- salicylic acid plaster

  • NDC Code(s): 53329-410-09, 53329-410-59
  • Packager: Medline Industries, LP
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 September 27, 2022

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

  • Active ingredient

    40% Salicylic Acid

  • Purpose

    Corn, Callus, and Wart Remover

  • Uses

    • for the removal of corns and calluses
    • Relieves pain by removing corns and calluses
    • for the removal of common warts. The common wart is easily recognized by the rough ‘cauliflower-like’ appearance of the surface
    • for the removal of plantar warts on the bottom of the foot. The plantar wart is recognized by its location only on the bottom of the foot, its tenderness, and the interruption of the footprint pattern.
  • Warnings

    For external use only. This product contains natural rubber, which may cause allergic reactions.

    Keep this and all drugs out of reach of children.

    In case of accidental ingestion, seek professional assistance or contact a Poison Control center immediately.

    Stop using this product and see your doctor if

    • discomfort persists for more than 72 hours

    Do Not Use

    • if you are diabetic or have poor blood circulation
    • on irritated skin or on any area that is infected or reddened
    • on moles, birthmarks, or warts with hair growing from them, genital warts, warts on the face, warts on mucous membranes such as warts inside the mouth, nose, anus, genitals or lips.
  • Directions

    • Wash affected area. May soak corn, callus or wart in warm water for 5 minutes. Dry area thoroughly. Cut pad to fit corn, callus or wart. Apply medicated pad to area. Remove medicated pad after 48 hours. Repeat procedure every 48 hours for up to 14 days for corn/callus removal and up to 12 weeks for warts, until the problem has cleared.
  • Inactive ingredients

    O-Cresol, Lanolin, Myroxylon pereirae (Balsam Peru), Phenol, Talc, Terpineol

    Bandage: Flannel (99.7% cotton), Colophonium, Rubber Latex, 0.3% Polyurethane

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Made in USA

    www.curad.com

    1-800-633-5463

    REF: CUR01496

    V2 RE22PCC

  • Package Labels

    Label V2 RE22PCC

  • INGREDIENTS AND APPEARANCE
    MEDIPLAST 
    salicylic acid plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID40 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PHENOL (UNII: 339NCG44TV)  
    LANOLIN (UNII: 7EV65EAW6H)  
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    BALSAM PERU (UNII: 8P5F881OCY)  
    ROSIN (UNII: 88S87KL877)  
    TALC (UNII: 7SEV7J4R1U)  
    TERPINEOL (UNII: R53Q4ZWC99)  
    ORTHOCRESOL (UNII: YW84DH5I7U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-410-5925 in 1 BOX08/01/2008
    11 in 1 PACKET
    11.4 g in 1 APPLICATOR; Type 0: Not a Combination Product
    2NDC:53329-410-091 in 1 PACKET08/01/2008
    21.4 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358F08/01/2008
    Labeler - Medline Industries, LP (025460908)