Label: PREPARATION H MEDICATED WIPES- witch hazel cloth

  • NDC Code(s): 0573-0556-07, 0573-0556-20, 0573-0556-96
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 16, 2020

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

  • ACTIVE INGREDIENT

    Witch hazel 50.0%

  • PURPOSE

    Astringent

  • USES

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

  • DIRECTIONS

    open the lid on the top of the wipes pouch
    peel back wipes seal, remove completely and discard
    grab the top wipe at the edge of the center fold and pull out of pouch
    close lid after each use to retain moisture
    adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area
    use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard
    children under 12 years of age: consult a doctor
  • OTHER INFORMATION

    for best results, flush only one or two wipes at a time
    store at 20-25°C (68-77°F)
  • INACTIVE INGREDIENTS

    aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

  • QUESTIONS OR COMMENTS?

    Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374

  • PRODUCT PACKAGING

    The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

    PREPARATION H Medicated Wipes

    Hemorrhoidal Wipes with Witch Hazel

    MAXIMUM STRENGTH FORMULA

    Gentle, Everyday Cleansing To Reduce Irritation

    48 Medicated Wipes With Aloe

    Cools, Soothes and Comforts

    Convenient, Easy to Use

    For Hemorrhoidal and Vaginal Care

    Flushable and Septic Safe

    6 x 5 in. (15.2 x 12.7 cm)

    For most recent product information, visit www.preparationh.com

    Marketed By Wyeth Consumer Healthcare

    Madison, NJ 07940 USA

    Made in USA ©2009 Wyeth

    10 Wipes Individually Wrapped

    Each wipe is enclosed in a sealed foil pouch. Do not use if the pouch is broken or torn.

    Other Uses

    for vaginal care – cleanse the area by gently wiping, patting or blotting. Repeat as needed.
    for use as a moist compress – if necessary, first cleanse the area as previously described. Fold new wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.
    Preparation H Medicated Wipes carton
  • INGREDIENTS AND APPEARANCE
    PREPARATION H MEDICATED WIPES 
    witch hazel cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0556
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL5 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CAPRYL/CAPRAMIDOPROPYL BETAINE (UNII: 231H3ZT9NE)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0556-0710 in 1 CARTON02/02/2004
    11 in 1 PACKET; Type 0: Not a Combination Product
    2NDC:0573-0556-962 in 1 CARTON02/02/2004
    2NDC:0573-0556-2048 in 1 POUCH; Type 0: Not a Combination Product
    3NDC:0573-0556-2048 in 1 POUCH; Type 0: Not a Combination Product02/02/2004
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/02/2004
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)