Label: CURIST MEDICATED WIPES MAXIMUM STRENGTH- witch hazel cloth

  • 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 August 4, 2022

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Witch hazel 50%

  • PURPOSE

    Purpose

    Astringent

  • INDICATIONS & USAGE

    Uses

    • helps relieve the itching and discomfort associated with hemorrhoids
    • temporary relief of irritation and burning
    • aids in protecting irritated anorectal areas
  • WARNINGS

    Warnings

    For external use only.

    When using this product

    • do not exceed the recommended daily dosage unless directed by a doctor
    • do not put this product into the rectum by using fingers or any mechanical device or applicator

    Stop use and ask a doctor if

    • 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. (1-800-222-1222)

  • DOSAGE & ADMINISTRATION

    Directions

    • adult: unfold wipe. 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 a soft cloth before application of this product.
    • use up to 6 times daily or after each bowel movement and before applying hemorrhoidal treatments, and then discard
    • children under 12 years of age: consult a doctor
    • flush or dispose of wipe in trash
    • *for best results, flush no more than one wipe at a time.
  • STORAGE AND HANDLING

    Other information

    store at room temperature 20 - 25°C (68 - 77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    Alcohol, Aloe, Citric Acid, Decyl Glucoside, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water.

  • QUESTIONS

    Questions? Call 1 (844) 243-1241 or email hi@curistrelief.com

  • SPL UNCLASSIFIED SECTION

    **This product is not affiliated with the owner of the registered trademark Preparation H©

    Other Uses:

    For vaginal care - cleanse the area by gently wiping, patting, or blotting. Repeat as needed.

    For use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for 15 minutes and repeat as needed.

    Distributed by:

    Little Pharma, Inc.

    New York, NY 10023

    Made in USA of globally sourced materials

  • PRINCIPAL DISPLAY PANEL

    curist

    Medicated Wipes

    Maximum Strength

    Compare to Preparation H © Medicated Wipes active ingredient**

    Medicated Hemorrhoidal Wipes with Witch Hazel 50%

    Everyday Use That Reduces Irritation

    Cools, Soothes, Cleanses, and Comforts

    No Fragrance Added, Flushable*, With Aloe

    48 Wipes

    6 in x 5 in (15.2 cm x 12.7 cm)

    Curist Medicated Wipes Maximum Strength PDP

  • INGREDIENTS AND APPEARANCE
    CURIST MEDICATED WIPES  MAXIMUM STRENGTH
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72559-022
    Route of AdministrationTOPICAL
    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
    ALOE (UNII: V5VD430YW9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72559-022-3048 in 1 POUCH09/01/2022
    13.4 mL in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01509/01/2022
    Labeler - LITTLE PHARMA, INC. (074328189)