Label: HEMORRHOID AND FISSURE DR. BUTLER- lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment

  • NDC Code(s): 70942-023-01, 70942-023-11
  • Packager: Beyond Health P.A.
  • 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 July 17, 2020

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  • ACTIVE INGREDIENT

  • PURPOSE

    Analgesic (pain relief), Vasoconstrictor

  • INDICATIONS & USAGE

    Helps relieve the anorectal symptoms associated with hemorrhoids (pain, soreness, burning, itching). Temporarily reduces the swelling associated with irritated hemorrhoidal tissue and other anorectal disorders.

  • WARNINGS

    For external and/or intrarectal use only.

    When using this product do not exceed recommended daily dosage unless directed by a doctor.

    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. 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. Introduction of applicator into the rectum causes additional pain.

    If pregnant or breastfeeding, ask a health professional before use.

  • 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

  • PRINCIPAL DISPLAY PANEL

    Cartonimage descriptionimage description

  • INGREDIENTS AND APPEARANCE
    HEMORRHOID AND FISSURE  DR. BUTLER
    lidocaine 4.00, phenylephrine hydrochloride 0.25 ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-023
    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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    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)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    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:70942-023-011 in 1 CARTON08/28/2007
    128 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:70942-023-111 in 1 CARTON08/27/2019
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34608/28/2007
    Labeler - Beyond Health P.A. (026781064)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derma Care Research Labs116817470manufacture(70942-023)