Label: HEMORROIDAL COOLING GEL- phenylephrine, witch hazel gel

  • NDC Code(s): 63868-483-18
  • Packager: Chain Drug Marketing Association
  • 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 May 23, 2023

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  • 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
  • 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)

    ** This product is not manufactured or distributed by Pfizer Consumer Healthcare, 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 1-800-935-2362

  • Distributed by

    C.D.M.A. Inc. ©

    43157 W 9 Mile Rd.

    Novi, MI. 48375 USA

    1-800-935-2362

    www.qualitychoice.com

    Product of PRC

  • Packaging

    QC Hemorrhoid Cooling Gel 1.8oz.

  • Packaging

    qc hemorrhoid cooling gel 1.8oz.

  • INGREDIENTS AND APPEARANCE
    HEMORROIDAL COOLING GEL 
    phenylephrine, witch hazel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-483
    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:63868-483-181 in 1 BOX07/15/2019
    151 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/15/2019
    Labeler - Chain Drug Marketing Association (011920774)
    Registrant - Trifecta Pharmaceuticals USA (079424163)
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