Label: DR BUTLERS HEMORRHOID AND FISSURE PF- lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment

  • 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 February 20, 2023

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

  • ACTIVE INGREDIENT

    Lidocaine 4%, Phenylephrine HCl 0.25%

  • PURPOSE

    Analgesic (pain relief), Vasoconstrictor

  • INDICATIONS & USAGE

    Temporarily shrinks hemorrhoidal tissue, for the temporary relief of pain, soreness, or burning, and helps relieve the local itching and discomfort associated with hemorrhoids.

  • WARNINGS

    For external use only including the skin of the anal canal.

    When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only. Do not put this product into the rectum.

    Ask a doctor before use if you have allergies to any of the components of this product, difficulty in urination due to enlargement of the prostate gland, diabetes, heart disease, high blood pressure, thyroid disease, or presently taking a prescription for high blood pressure or depression.

    Stop use and ask a doctor if condition worsens or does not improve within seven days, bleeding occurs, an allergic reaction develops, the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Children under 12 years of age consult your pediatrician.

    Adults: apply to affected area up to 3 times daily.

    Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.

    To use dispensing cap, attach it to tube, lubricate well then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

  • INACTIVE INGREDIENT

    Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, octyldodecanol, olea europaea (olive) fruit oil, panax ginseng root extract, PEG-8 dimehticone, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, pyridoxine HCl, retinyl palmitate, silica, sodium hyaluronate, sodium propoxyhydroxypropyl thiosulfate silica, stearic acid, tocopheryl acetate, triethoxycaprylysilance, water, zea mays (corn) oil, zinc oxide

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health care professional before use.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    DR BUTLERS HEMORRHOID AND FISSURE PF 
    lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-357
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE0.25 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    ALOE (UNII: V5VD430YW9)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    TRICAPRYLIN (UNII: 6P92858988)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    HYDROCORTISONE (UNII: WI4X0X7BPJ)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SODIUM PROPOXYHYDROXYPROPYL THIOSULFATE SILICA (UNII: 208G222332)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    WATER (UNII: 059QF0KO0R)  
    CORN OIL (UNII: 8470G57WFM)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70942-357-011 in 1 CARTON02/20/2023
    128 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34602/20/2023
    Labeler - Beyond Health P.A. (026781064)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(70942-357)