Label: DOCTOR BUTLERS HEMORRHOID AND FISSURE EXTERNAL PAIN FORMULA- lidocaine 5% ointment

  • NDC Code(s): 70942-121-01, 70942-121-11
  • Packager: Beyond Health, P.A.
  • 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

    Lidocaine 5.0%

  • PURPOSE

    Local Anesthetic

  • Uses

    Helps relieve the local itching and discomfort associated with anorectal disorders or inflammation.

  • WARNINGS

    For external use only.

    When using this product avoid contact with eyes, do not exceed recommended dosage unless directed by a doctor, do not put this product into the rectum by using fingers or any mechanical device or applicator.

    Stop use and ask a doctor if rectal bleeding occurs, condition worsens or does not improve within 7 days, allergic reaction occurs to ingredients in this product, symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase, or symptoms clear up and return within a few days.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a 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

    • When practical, cleanse the area with mild soap and warm water. Rinse thoroughly and gently pat dry.
    • Adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
    • Children under 12 years of age: consult a doctor.
  • INACTIVE INGREDIENT

    Aesculus Hippocastanum (Horse Chestnut) Extract, Benzyl Alcohol, Calendula Officinalis Flower Extract, Calendula Officinalis flower Extract, Carbomer, Carya Ovata Bark Extract, Centella Asiatica Extract, Chamomilla Recutita (Matricaria) Flower Extract, Cholesterol, Curcuma Longa (Turmeric) Root Extract, Hamamelis Virginiana (Witch Hazel) Leaf Extract, Helichrysum Italicum Extract, Hydrogenated Lecithin, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Flower Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Olea Europaea (Olive) Leaf Extract, Panax Ginseng Root Extract, Polysorbate 80, Propylene Glycol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Hyaluronate, Tocopheryl Acetate, Triethanolamine, Water.

  • PRINCIPAL DISPLAY PANEL

    Carton

  • INGREDIENTS AND APPEARANCE
    DOCTOR BUTLERS HEMORRHOID AND FISSURE  EXTERNAL PAIN FORMULA
    lidocaine 5% ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70942-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    TURMERIC (UNII: 856YO1Z64F)  
    HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)  
    CARYA OVATA BARK (UNII: X765CF609L)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    ROSEMARY (UNII: IJ67X351P9)  
    MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70942-121-0128 g in 1 TUBE; Type 0: Not a Combination Product03/01/2022
    2NDC:70942-121-1128 g in 1 TUBE; Type 0: Not a Combination Product03/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01503/01/2022
    Labeler - Beyond Health, P.A. (026781064)
    Registrant - Derma Care Research Labs (116817470)
    Establishment
    NameAddressID/FEIBusiness Operations
    Derrma Care Research Labs116817470manufacture(70942-121)