WART REMOVER (SALICYLIC ACID) PLASTER [PHARMAPLAST SAE]

WART REMOVER (SALICYLIC ACID) PLASTER [PHARMAPLAST SAE]
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NDC 28691-0400-1
Set ID a581fcf8-b406-48af-b358-87531e3486a2
Category HUMAN OTC DRUG LABEL
Packager Pharmaplast SAE
Generic Name
Product Class
Product Number
Application Number PART358B
  • Drug Facts

  • Active ingredient

    Salicylic acid 40% in a plaster vehicle

  • Purpose

    Wart remover adhesive pads

  • Indications:

    • 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
    • Do not use this product on irritated skin, on any area that is infected or reddened, if you are a diabetic, or if you have poor blood circulation.
    • If discomfort persists, see your doctor.
    • Do not use on moles, birthmarks, warts with hair growing from them, genital warts, or warts on the face or mucous membranes.

    • Keep out of reach of children.
  • Directions

    For removal of Common and Plantar warts:

    • Wash affected area.
    • May soak wart in warm water for 5 minutes.
    • Dry area thoroughly.
    • Cut plaster to fit wart.
    • Apply medicated plaster.
    • Repeat procedure every 48 hours as needed (until wart is removed) for up to 12 weeks.
  • Inactive ingredient

    Pressure sensitive adhesive fabric

  • SPL UNCLASSIFIED SECTION

    CURE-AID®

    Pharmaplast

    Amria – Alexandria
    Egypt
    www.Pharmaplast-online.com

  • Packaging

    Label

  • INGREDIENTS AND APPEARANCE
    WART REMOVER 
    salicylic acid plaster
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28691-0400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.4 g
    Inactive Ingredients
    Ingredient NameStrength
    NATURAL LATEX RUBBER (UNII: 2LQ0UUW8IN)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYISOBUTYLENE (75000 MW) (UNII: 596C33NS2J)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28691-0400-120 in 1 BOX; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug10/07/201608/22/2019
    2NDC:28691-0400-210 in 1 BOX; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug08/22/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358B10/07/2016
    Labeler - Pharmaplast SAE (644773319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmaplast SAE644773319manufacture(28691-0400)

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