Label: DUDE HEMORRHOIDAL WIPES- witch hazel cloth

  • NDC Code(s): 83731-055-03, 83731-055-48
  • Packager: Dude Products
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 15, 2024

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  • Active Ingredient

    Witch Hazel 25%

  • Purpose

    Astringent

  • Uses

    • Temporarily relieves these external symptoms associated with hemorrhoids:
    • Itching • burning • irritation

  • Warnings

    For external use only

  • When using this product

    • Do not exceed the recommended daily dosage unless directed by a doctor.

    • Do not insert in rectum using fingers or mechanical device.

  • Stop use and ask a doctor if

    • Rectal bleeding occurs or;

    • If condition worsens or does not improve within 7 days

  • Keep out of reach of children

    if swallowed, get medical help, or contact a Poison Control Center right away.

  • Directions

    As a hemorrhoidal treatment for adults:

    • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.

    • Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
    • Gently apply to the affected area by patting and then discard.
    Children under 12 years of age: Consult a doctor

  • Dosage

    Can be used up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments.

  • Storage

    Storage: Store at room temperature.

  • Inactive ingredients

    ALOE BARBADENSIS LEAF EXTRACT, DISODIUM COCOAMPHODIACETATE, GLUCONIC ACID, GLYCERIN, SODIUM BENZOATE, SODIUM CITRATE DIHYDRATE, TOCOPHERYL ACETATE, WATER

  • Questions or Comments

    1-877-432-4411

  • Package Label

    Back Bundle LabelFront Bundle LabelHemi

  • INGREDIENTS AND APPEARANCE
    DUDE HEMORRHOIDAL WIPES 
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83731-055
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL1.5 g
    Inactive Ingredients
    Ingredient NameStrength
    GLUCONIC ACID (UNII: R4R8J0Q44B)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83731-055-4848 in 1 PACKAGE; Type 0: Not a Combination Product01/14/2024
    2NDC:83731-055-033 in 1 PACKAGE12/31/2024
    2NDC:83731-055-4848 in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/14/2024
    Labeler - Dude Products (078446360)
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