Label: DR. BUTLER HEMORRHOID TREATMENT- phenylephrine hydrochloride 0.25%, witch hazel 50% spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 15, 2024

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

  • ACTIVE INGREDIENT

    Phenylephrine HCl 0.25%, Witch Hazel 50%

  • PURPOSE

    Vasoconstrictor, Astringent

  • INDICATIONS & USAGE

    Temporarily reduces swelling associated with hemorrhoidal tissue. Temporary relief of anorectal itching and discomfort associated with hemorrhoids and other anorectal disorders.

  • WARNINGS

    For external use only.

    When using this product avoid spraying in eyes, contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F, do not exceed recommended daily dosage unless directed by a doctor, do not put this product in the rectum by using fingers or any mechanical device or applicator.

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

    Stop use and ask a doctor if bleeding occurs, the condition worsens, symptoms last more than 7 days or clear up and occur again within a few days, needed for longer than 1 week.

    Ask a healthcare or professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, seek medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Adults: when practical, cleanse the affected area with mild soap and warm water and pat dry. Spray the rectal area until thoroughly moist. Wipe off excess with a tissue, gently dry by patting or blotting with a tissue or a soft cloth, apply to the affected area up to 4 times daily especially at night in the morning or after each bowel movement. For children under 12 years of age, consult a doctor.

  • INACTIVE INGREDIENT

    Alcohol, Aloe Barbadensis Leaf Extract, Benzophenone-4, Benzyl Alcohol, Disodium EDTA, Ethylhexylglycerin, Hydroxyethylcellulose, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium Citrate, Tocopherol, Tocopheryl Acetate, Water.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    DR. BUTLER HEMORRHOID TREATMENT 
    phenylephrine hydrochloride 0.25%, witch hazel 50% spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WITCH HAZEL (UNII: 101I4J0U34) (WITCH HAZEL - UNII:101I4J0U34) WITCH HAZEL50 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SULISOBENZONE (UNII: 1W6L629B4K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE (UNII: V5VD430YW9)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70942-135-031 in 1 CARTON12/10/2021
    185 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01512/10/2021
    Labeler - Beyond Health P.A. (026781064)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(70942-135)