Label: PREPARATION H COOLING GEL- phenylephrine hcl, witch hazel gel

  • NDC Code(s): 0573-2840-10, 0573-2840-20
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated April 5, 2024

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  • Active ingredients

    Phenylephrine HCl 0.25%

    Witch hazel 50.0%

  • Purposes

    Vasoconstrictor

    Astringent

  • Uses

    • helps relieve the local itching and discomfort associated with hemorrhoids
    • temporary relief of irritation and burning
    • temporarily shrinks hemorrhoidal tissue
    • aids in protecting irritated anorectal areas
  • Warnings

    For external 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 are

    presently taking a prescription drug for high blood pressure or depression.

    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: 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 applying gel.
    • when first opening the tube, puncture foil seal with top end of cap
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
    • children under 12 years of age: ask a doctor
  • Other information

    store at 20-25°C (68-77°F)

  • Inactive ingredients

    aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E acetate

  • Questions or comments?

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

    Additional information

    Do Not Use if tube seal under cap embossed with “H” is broken or missing.

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

    Trademarks owned or licensed by GSK

    ©2021 GSK or licensor

    Made In Canada

    Do Not Use if tube seal under cap embossed with “H” is broken or missing.

  • PRINCIPAL DISPLAY PANEL

    PREPARATION H

    HEMORRHOIDAL
    COOLING
    GEL

    Fast Cooling
    Relief

    • Clear, Non-Greasy Formula with
      No Unpleasant Scent
    • Prompt, Cooling Relief from Painful
      Burning & Itching
    • Shrinks Swollen Hemorrhoidal Tissue
    • Relieves External Discomfort

    1 TUBE | NET WT 1.8 OZ (51 g)

    PAA162794 Front Carton

    PrepH Cooling Gel 1.8 oz (51 g)
  • INGREDIENTS AND APPEARANCE
    PREPARATION H COOLING GEL 
    phenylephrine hcl, witch hazel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2840
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE2.5 mg  in 1 g
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL500 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%) (UNII: 8136Y38GY5)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2840-101 in 1 CARTON01/01/2004
    126 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0573-2840-201 in 1 CARTON01/01/2004
    251 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01501/01/2004
    Labeler - Haleon US Holdings LLC (079944263)
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