Label: HEMORROIDAL COOLING GEL- phenylephrine, witch hazel gel

  • NDC Code(s): 69396-032-18
  • Packager: Trifecta Pharmaceuticals Usa Llc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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

  • Drug Facts

  • Active Ingredient

    Phenylephrine HCI 0.25%

  • Purpose

    Vasoconstrictor

  • Active Ingredient

    Witch Hazel 50%

  • Purpose

    Astringent

  • Uses

    • Helps relieve the local itching and discomfort associated with hemorrhoids
    • temporarily relief of irritation and burning
    • temporarily shrinks hemorrhoidal tissue
    • aids in protecting irritated anorectal areas
  • Stop use and ask a doctor

    • bleeding occurs
    • condition worsens or does not improve within 7 days
    • introduction of applicator into the rectum causes additional pain
  • If pregnant or breast feeding

    Ask a doctor before use

  • Keep out of the reach of children

    If swallowed get medical help or contact Poison Control Center right away

  • Directions

    Children under 12 years of age; ask a doctor before use

    Adults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipe

    • gently dry by patting or blotting with a tissue or soft cloth before applying
    • when first opening tube, remove foil seal
    • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • Warnings

    For External Use Only

    Ask doctor before use if you have

    • heart disease
    • high blood pressure
    • thyroid disease
    • diabetes
    • difficulty urinating due to an enlarged prostate gland

    Ask doctor 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 into the rectum by using fingers or any mechanical device or applicator
  • Other information

    Store at room temperature 20°-25°C (68°-77°F)

    Do not use if tube seal under cap is broken or missing

    ** This product is not manufactured or distributed by Wyeth Consumer Healthcare Inc. owner of the registered trademark Preparation H®

  • Inactive Ingredients

    Aloe barbadensis gel, benzophenone-4, Acetate disodium, Hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, Vitamin E, water

  • Questions or Comments

    Call Toll Free 1-888-296-9067

  • Distributed By

    Trifecta Pharmaceuticals USA™

    101 NE Third Avenue, Suite 1500

    Ft. Lauderdale, FL. 33301, USA

    1-888-296-9067

  • Packaging

    globe_cooling_gel

  • INGREDIENTS AND APPEARANCE
    HEMORROIDAL COOLING GEL 
    phenylephrine, witch hazel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-032
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL0.5 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69396-032-181 in 1 BOX02/13/2018
    156 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01502/13/2018
    Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)