Label: PREPARATION H- cocoa butter, phenylephrine hydrochloride, and witch hazel kit

  • NDC Code(s): 0573-2884-12
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 5, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Active Ingredients

    Cocoa butter 88.44%

    Phenylephrine HCl 0.25%

    Purposes

    Protectant

    Vasoconstrictor

  • Uses

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily relieves burning and shrinks hemorrhoidal tissue
    • temporarily provides a coating for relief of anorectal discomforts
    • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful
  • Warnings

    For rectal use only

    Ask a doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty in urination due to enlargement of the prostate gland

    Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

    When using this productdo not exceed the recommended daily dosage unless directed by a doctor

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens or does not improve within 7 days

    If pregnant or breast-feeding,ask a health professional before use.

    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 wipe. Gently dry by patting or blotting with a tissue or a soft cloth before insertion of this product.
    • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:
    1. hold suppository with rounded end up
    2. as shown, carefully separate foil tabs by inserting tip of fingernail at end marked "peel down"
    3. slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository
    4. remove exposed suppository from wrapper
    5. insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement
    Image 1
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    • children under 12 years of age: ask a doctor
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive ingredients

    corn starch, methylparaben, propylparaben

  • Questions or comments?

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

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

  • SPL UNCLASSIFIED SECTION

    Preparation H ®Totables ®Irritation Relief Wipes

    Drug Facts

  • 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

    If pregnant or breast-feeding,ask a health professional before use.

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • 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

    • store at 20-25°C (68-77°F)
    • for best results, flush only one or two wipes at a time
  • 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 1-800-99PrepHor 1-800-997-7374.

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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    SAME AMOUNT
    Smaller Package

    PREPARATION H ®
    HEMORRHOIDAL
    SUPPOSITORIES

    Provides Relief from
    MULTIPLE SYMPTOMS

    • Reduces Internal Swelling,
      Soothes & Protects
    • Prompt Soothing Relief
      from Painful Burning,
      Itching and Discomfort
    • Also for Nighttime Relief

    + 4 FREE
    WIPESINSIDE

    12 SUPPOSITORIES

    Principal Display Panel - Kit Carton
  • INGREDIENTS AND APPEARANCE
    PREPARATION H 
    cocoa butter, phenylephrine hydrochloride, and witch hazel kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2884
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2884-121 in 1 CARTON; Type 0: Not a Combination Product07/01/2015
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BLISTER PACK 12 
    Part 21 APPLICATOR
    Part 1 of 2
    PREPARATION H 
    cocoa butter and phenylephrine hydrochloride suppository
    Product Information
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COCOA BUTTER (UNII: 512OYT1CRR) (COCOA BUTTER - UNII:512OYT1CRR) COCOA BUTTER2211 mg
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE6.25 mg
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Coloryellow (Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    112 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01507/01/2015
    Part 2 of 2
    PREPARATION H TOTABLES IRRITATION RELIEF WIPES 
    witch hazel cloth
    Product Information
    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, (R)- (UNII: 602HN5L69H)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Product Characteristics
    Colorwhite (white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01507/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01507/01/2015
    Labeler - Haleon US Holdings LLC (079944263)