Label: HEMORRHOIDAL HYGIENE PADS- witch hazel solution

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

Drug Label Information

Updated September 21, 2024

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  • Drug Facts

    Witch Hazel 50%
    Purpose: Hemorrhoidal Astringent

  • Uses

    For temporary relief of local discomfort,
    burning and irritation associated with Hemorrhoids

  • WARNINGS

    For External Use Only

    • Avoid contact with the eyes

    Consult a doctor

    • If condition worsens or does not improve within 7 days
    • In case of bleeding
    • Before exceeding the recommended dosage

    DO NOT put this product into the rectum using fingers or any mechanical device.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    • If swallowed, get medical attention or contact the Poison Control Center immediately.
  • Directions:

    • When practical, clean the affected area with mild soap and warm water, and rinse thoroughly
  • DOSAGE & ADMINISTRATION

    • Gently dry by patting or blotting with toilet tissue or a soft cloth before applying
    • Apply externally to the affected area up to 6 times daily or after each bowel movement 
    • After application, discard pad Children under 12 years of age: consult a doctor
  • Other Information

    • Store at room temperature 15°-30°C (59°-86°F)
    • If adverse effects call 1-877-225-6999
  • Other Ingredients

    Alcohol, Citric Acid, Deionized Water, DMDM Hydantoin,Glycerin, Sodium Citrate.

  • PRINCIPAL DISPLAY PANEL

    patch

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL HYGIENE PADS 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71399-0110
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71399-0110-1175 mL in 1 JAR; Type 0: Not a Combination Product09/13/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01509/13/2024
    Labeler - Akron Pharma Inc. (067878881)
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