Label: DOCTOR BUTLER HEMORRHOID AND FISSURE ADVANCED FORMULA- glycerin 37.5%, lanolin 12.5%, lidocaine 4%, zinc oxide 5% ointment

  • 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

    Glycerin 37.5%, Lanolin 12.5%, Lidocaine 4%, Zinc Oxide 5%

  • PURPOSE

    Anorectal (Hemorrhoidal)

  • Uses

    Helps relieve the pain, itching, and burning associated with hemorrhoids and other anorectal disorders.

  • WARNINGS

    For external and/or intrarectal use only.

    When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor. Certain persons can develop allergic reactions to ingredients in this product. If the symptom 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 before use if you have allergies to any of the components of this product.

    Stop use and ask a doctor if condition worsens or does not improve within seven days or bleeding occurs.

  • PREGNANCY

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    • Children under 12 years of age consult your pediatrician.
    • Adults: Apply to the affected area up to 3 times daily.
    • Clean affected area with mild soap and warm water, rinse thoroughly, and gently dry (patting or blotting) with tissue or soft cloth before use.
    • The ointment can be applied using a gloved finger or finger cot.
    • To use finger cots: roll one finger cot over finger. Gently squeeze ointment onto finger cot. Smooth a layer of the ointment over affected area or into anus.
  • INACTIVE INGREDIENT

    Aesculus Hippocastanum (Horse Chestnut) Extract

    Algae Extract

    Argania Spinosa Kernel Oil

    Benzyl Alcohol

    Calendula Officinalis Flower Extract

    Camellia Sinensis Leaf Extract

    Cananga Odorata Flower Oil

    Canola Oil

    Caprylhydroxamic Acid

    Caprylic/Capric Triglyceride

    Centella Asiatica Extract

    Chamomilla Recutita (Matricaria) Flower Extract

    Cocos Nucifera (Coconut) Oil

    Curcuma Longa (Turmeric) Root Extract

    Euphorbia Cerifera (Candelilla) Wax

    Glyceryl Caprylate

    Helianthus Annuus (Sunflower) Seed Oil

    Helianthus Annuus (Sunflower) Seed Wax

    Hydrocortisone

    Lavandula Angustifolia (Lavender) Oil

    Linum Usitatissimum (Linseed) Seed Oil

    Lysine HCl

    Macadamia Ternifolia Seed Oil

    Olea Europaea (Olive) Fruit Oil

    Panax Ginseng Root Extract

    Persea Gratissima (Avocado) Oil

    Pogostemon Cablin Oil

    Polyhydroxystearic Acid

    Punica Granatum Fruit Extract

    Ricinus Communis (Castor) Seed Oil

    Rosa Canina Seed Oil

    Sodium Hyaluronate

    Tocopheryl Acetate

    Triethoxycaprylylsilane

    Viburnum Opulus Bark Extract

    Water

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    DOCTOR BUTLER HEMORRHOID AND FISSURE  ADVANCED FORMULA
    glycerin 37.5%, lanolin 12.5%, lidocaine 4%, zinc oxide 5% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-517
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN37.5 g  in 100 g
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 g  in 100 g
    LANOLIN (UNII: 7EV65EAW6H) (LANOLIN - UNII:7EV65EAW6H) LANOLIN12.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    VIBURNUM OPULUS WHOLE (UNII: DIO510WJ04)  
    WATER (UNII: 059QF0KO0R)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HYDROCORTISONE (UNII: WI4X0X7BPJ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ROSA CANINA SEED OIL (UNII: MHT97MG5P8)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POGOSTEMON CABLIN LEAF OIL (UNII: F3IN55X5PO)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CANOLA OIL (UNII: 331KBJ17RK)  
    CANANGA OIL (UNII: 8YOY78GNNX)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    TURMERIC (UNII: 856YO1Z64F)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70942-517-011 in 1 CARTON09/20/2021
    142.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01509/20/2021
    Labeler - Beyond Health, PA (026781064)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derrma Care Research Labs116817470manufacture(70942-517)