Label: FLUSHABLE HEMORRHOIDAL MEDICAL WIPES- witch hazel patch

  • 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 March 31, 2020

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

  • Active Ingredient

    Witch Hazel 50%

  • Purpose

    Hemorrhoidal 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 into rectum or vagina using fingers or mechanical device.

    Stop use and ask a doctor if

    • rectal bleeding occurs
    • 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 at 1-800-222-1222.

  • Directions

    As 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.
    • can be used up to six times daily or after each bowel movement.

    Children under 12 years of age

    • consult a doctor.
  • Other Information

    Store at controlled room temperature: 15º-30ºC (59º-86ºF)

  • Inactive Ingredients

    Water, Aloe Barbadensis Leaf Extract, Sodium Citrate, Citric Acid, Glycerin, Phenoxyethanol, Potassium Sorbate

  • OTHER SAFETY INFORMATION

    Flush only one wipe at a time. Keep lid tightly closed when not in use.

    Gently pull out wipe to dispense

    Safe for well-maintained sewers and septic systems

    Not recommended for use with basement pump systems

  • Principal Display Panel

    NDC 30142-314-48

    COMPARE TO the active ingredient of PREPARATION H® MEDICATED WIPES

    *See back panel

    Kroger®

    MAXIMUM STRENGTH

    Flushable Hemorrhoidal Medicated Wipes

    Witch Hazel, 50%

    Gentle Everyday Cleansing to Reduce Irritation

    With Aloe

    PRE˜MOISTENED Cools, Soothes & Comforts Convenient, Easy to Use

    48 MEDICATED WIPES 6.0 IN x 5.0 IN (15.2 cm x 12.7 cm)

    Label

    NDC 30142-314-96

    COMPARE TO the active ingredient of PREPARATION H® MEDICATED WIPES

    *See bottom panel

    Kroger®

    MAXIMUM STRENGTH

    Flushable Hemorrhoidal Medicated Wipes

    Witch Hazel, 50%

    Gentle Everyday Cleansing to Reduce Irritation

    With Aloe

    PRE˜MOISTENED Cools, Soothes & Comforts Convenient, Easy to Use

    2 X 48 CT PACKS

    96 MEDICATED WIPES

    Lable 1

  • INGREDIENTS AND APPEARANCE
    FLUSHABLE HEMORRHOIDAL MEDICAL WIPES 
    witch hazel patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:30142-314
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1000 mg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:30142-314-4848 in 1 BOX03/31/2020
    1500 mg in 1 PATCH; Type 0: Not a Combination Product
    2NDC:30142-314-9696 in 1 BOX03/31/2020
    2500 mg in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/31/2020
    Labeler - Kroger Company (006999528)