Label: LIDOCAINE HEMORRHOID- lidocaine hcl, phenylephrine hcl, witch hazel spray

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

Drug Label Information

Updated February 5, 2024

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

  • ACTIVE INGREDIENT

    Lidocaine HCl 5%, Phenylephrine HCl 0.25%, Witch Hazel 50%

  • PURPOSE

    Anorectal; anesthetic, vasoconstrictor, astringent

  • INDICATIONS & USAGE

    • Temporarily shrinks hemorrhoidal tissue
    • Temporarily reduces the swelling and irritation associated with hemorrhoids and other anorectal disorders
    • aids in protecting irritated anorectal areas
  • INDICATIONS & USAGE

    Temporarily shrinks hemorrhoidal tissue. Temporarily reduces the swelling and irritation associated with hemorrhoids and other anorectal disorders. Aids in protecting irritated anorectal areas.

  • WARNINGS

    For external use only.

    Flammable. Do not use while smoking or near heat or flame.

    When using this product

    • keep away from children
    • avoid spraying in eyes
    • contents under pressure. Do not puncture or incinerate. Do not store at temperatures above 120F
    • 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
    • certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, discontinue use and consult a doctor.

    Ask a doctor or pharmacist before use if you have

    • heart disease, high blood pressure, thyroid disease, diabetes, difficulty in urination due to enlargement of the prostate gland
    • are presently taking a prescription drug for high blood pressure or depression

    Stop use and ask a doctor if

    • bleeding occurs
    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
    • needed for longer than 1 week
  • PREGNANCY 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 immediately (1-800-222-1222).

  • DOSAGE & ADMINISTRATION

    • Adults: when practical, cleanse the affected are with an appropriate cleansing wipe.
    • Spray rectal area until thoroughly moist. Wipe off excess with 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.
    • Children under 12 years of age, consult a doctor.
  • INACTIVE INGREDIENT

    alcohol, aloe barbadensis leaf extract, anthemis nobilis flower extract, benzophenone-4, benzyl alcohol, centella asiatica extract,disodium EDTA, epilobium angustifolium extract, ethylhexylglycerin, glycerin, hydroxyethylcellulose, polysorbte 40, propylene glycol, sodium citrate, tocopherol, tocopheryl acetate, water.

  • QUESTIONS

    1-800-925-4733

  • PRINCIPAL DISPLAY PANEL

    Label

  • INGREDIENTS AND APPEARANCE
    LIDOCAINE HEMORRHOID 
    lidocaine hcl, phenylephrine hcl, witch hazel spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1657
    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) PHENYLEPHRINE HYDROCHLORIDE0.25 g  in 100 g
    LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    POLYSORBATE 40 (UNII: STI11B5A2X)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    WATER (UNII: 059QF0KO0R)  
    SULISOBENZONE (UNII: 1W6L629B4K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALCOHOL (UNII: 3K9958V90M)  
    EPILOBIUM ANGUSTIFOLIUM LEAF (UNII: 7NV86426N2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1657-0385 g in 1 CAN; Type 0: Not a Combination Product02/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01502/05/2024
    Labeler - Walgreens Co (008965063)
    Registrant - Derma Care Research Labs, LLC (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs, LLC116817470manufacture(0363-1657)