Label: PREPARATION H SOOTHING RELIEF COOLING- witch hazel aerosol, spray

  • NDC Code(s): 0573-2889-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 2, 2024

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  • Active ingredients

    Witch hazel 20%

  • 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
    • Warning– avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.
    • Warning– use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    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

    • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying the spray.
    • apply externally to the affected area up to 6 times daily or after each bowel movement
    • children under 12 years of age: consult a doctor
    • shake well before using
    • hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
  • Other information

    • store at 20-25°C (68-77°F)
  • Inactive ingredients

    aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, dehydroxanthan gum, edetate disodium, glycerin, isobutane, propylene glycol, purified water, sodium benzoate, sodium citrate

  • Questions?

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

  • Additional information

    No Touch Spray

    Do not use if sleeve band around cap is broken or missing

    Dist. By: GSK Consumer Healthcare

    Warren, NJ 07059

    Trademarks owned or licensed by GSK

    ©2021 GSK or licensor

    PAA172637 (Front Carton)

  • PRINCIPAL DISPLAY PANEL

    NDC 0573-2889-01

    PREPARATION H

    NEW!

    soothing
    RELIEF
    cooling spray

    HEMORRHOIDAL SPRAY

    with ALOE

    Quickly Soothes and Cools Discomfort

    Relieves Itching, Burning and Irritation

    Gentle for Daily Use

    NET WT 2.7 OZ (77 g)

    Prep H Soothing Relief Cooling Spray 2.7oz (77 g)
  • INGREDIENTS AND APPEARANCE
    PREPARATION H   SOOTHING RELIEF COOLING
    witch hazel aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2889
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2889-0177 g in 1 CANISTER; Type 0: Not a Combination Product04/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01504/12/2021
    Labeler - Haleon US Holdings LLC (079944263)
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