Doctor Butler's Hemorrhoid and Fissure Cream External Pain Formula

Manufacturer
Beyond Health, P.A.
Effective date
2025-09-30
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:15:21

Label at a glance#

ProductDoctor Butlers Hemorrhoid and Fissure External Pain Formula
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

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

Dosage and administration

When practical, cleanse the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. 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.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine USP 5.0%

Purpose

OTC - PURPOSE SECTION

Analgesic (pain reliever)

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only including the skin of the anal canal

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reactions to ilgredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • When practical, cleanse the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • 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.

Other information

SPL UNCLASSIFIED SECTION

  • store at 15º-30º C (59ºto 86º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aesculus Hippocastanum (Horse Chestnut) Extract, Benzyl Alcohol, 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.

0.75 oz / 21.3g tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

1.5oz / 42.5g jar

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp_jarpdp_jar

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN6
1366789lidocaine 50 MG/ML Rectal CreamSCD6
1366789lidocaine 5 % Rectal CreamSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70942-121-01Doctor Butlers Hemorrhoid and FissureExternal Pain Formula28 g in 1 TUBECREAM286
70942-121-07Doctor Butlers Hemorrhoid and FissureExternal Pain Formula21.3 g in 1 TUBECREAM21.36
70942-121-11Doctor Butlers Hemorrhoid and FissureExternal Pain Formula28 g in 1 TUBECREAM286
70942-121-42Doctor Butlers Hemorrhoid and FissureExternal Pain Formula42.5 g in 1 JARCREAM42.56
70942-121-75Doctor Butlers Hemorrhoid and FissureExternal Pain Formula1 in 1 CARTONCREAM16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70942-121-75GM - Gram70942-121efda28e4-def8-4819-8716-64ddc2e1bd6b12025-09-12

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70942-12170942-121-01, 70942-121-11, 70942-121-07, 70942-121-75, 70942-121-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Doctor Butlers Hemorrhoid and Fissure External Pain FormulaLIDOCAINE 5%Beyond Health, P.A.d92f22a7-c0b5-d8b8-e053-2a95a90a23762025-09-30WarningsExact identifier
ndc (package): 70942-121-75
ndc (package): 70942-121-01
ndc (package): 70942-121-07
ndc (package): 70942-121-42
ndc (package): 70942-121-11
ndc (product): 70942-121
ndc11 (package): 70942012142
ndc11 (package): 70942012101
ndc11 (package): 70942012111
ndc11 (package): 70942012175
ndc11 (package): 70942012107
spl id: 40079b30-9401-2783-e063-6394a90acd0b
spl set id: d92f22a7-c0b5-d8b8-e053-2a95a90a2376

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.