Label: HEMORRHOIDAL COOLING- phenylephrine hcl, witch hazel gel

  • 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 April 12, 2022

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  • Active ingredient

    Phenylephrine HCl 0.25%

    Witch hazel 50%

  • Purpose

    Vasoconstrictor

    Astringent

  • Use

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

    For external use only

  • Do not use

    this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor

  • 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
    • in case of bleeding, consult a doctor promptly
  • stop use and ask a doctor if

    condition worsens or does not improve with in 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 appropriate cleansing pad.  Gently dry by patting or blotting with toilet tissue or a soft cloth before appliacation of this product
    • when you first opening the tube, remove foil under cap
    • apply externally to affected area up to 4 times daily
    • children under 12 years of age: ask a doctor
  • Other information

    store between 15° - 30° C (58° - 86 ° F)

  • Inactive ingredients

    Aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, sodium citrate, water

  • Questions or comments?

    Call 1-888-593-0593

  • Pharmacist Survery

    Walgreens Pharmacist Survey Study, November 2014

    This product is not manufactured or distributed by Pfizer Consumer Health care, distributor of Preparation H Hemorrhidal Cooling Gel.

  • Adverse Reactions Section

    DISTRIBUTED BY: WALGREEN CO.

    200 WILMOT RD., DEERFIELD, IL 60015

    WALLGREENS 100% SATISFACTION GUARANTEED

    walgreens.com

  • principal display panel

    Well at

    Walgreens

    Hemorrhoidal Cooling Gel

    Quick, Cooling Relief/With Soothing Aloe

    • Clear, non-greasy formula, with no unpleasant scent
    • Temporarily shrinks swollen hemorrhoidal tissue
    • Quick, cooling relief from burning & itching
    • Temporarily relieves irritation

    Compare to Preparathion H Hemorrhoidal Cooling Gel active ingredients

    NET WT 0.9 OZ (25.5 g)

    image description

  • INGREDIENTS AND APPEARANCE
    HEMORRHOIDAL COOLING 
    phenylephrine hcl, witch hazel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0086
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE24.8 g  in 1 g
    witch hazel (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) witch hazel497 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%) (UNII: S38J6RZN16)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0086-011 in 1 BOX07/30/2016
    125.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/30/2016
    Labeler - Walgreens (008965063)
    Registrant - Vi-Jon, LLC (790752542)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC088520668manufacture(0363-0086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vi-Jon, LLC790752542manufacture(0363-0086)
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