Label: HEMORRHOIDAL HYGIENE PADS- witch hazel solution

  • 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 December 24, 2018

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

View All Sections
  • Drug Facts

    Witch Hazel 50%
    Purpose: Hemorrhoidal Astringent

  • Uses

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

  • Directions

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

  • DOSAGE & ADMINISTRATION

    Apply externally to the affected area up to
    6 times daily or after each bowel movement

  • 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.

  • Other Ingredient

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

  • STORAGE AND HANDLING

    Store at room temperature 15°-30°C
    (59°-86°F)

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, contact the Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL HYGIENE PADS 
    witch hazel solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-004
    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)  
    ACETYLTRIBUTYL CITRATE (UNII: 0ZBX0N59RZ)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54162-004-2545 mL in 1 JAR; Type 0: Not a Combination Product07/31/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/31/2015
    Labeler - Geritrex, LLC (112796248)
    Establishment
    NameAddressID/FEIBusiness Operations
    Geritrex, LLC112796248manufacture(54162-004)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!