FDA.reportPublic FDA data

Doctor Butler's Hemorrhoid and Fissure Cream External Pain Formula

Manufacturer
Beyond Health, P.A.
Effective date
2026-10-22
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
daily-update
Hydrated at
2026-10-27 02:01:47

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 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.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
TURMERIC856YO1Z64FIACT
HAMAMELIS VIRGINIANA LEAFT07U1161SVIACT
CARYA OVATA BARKX765CF609LIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER 9404Q93RCW27EIACT
POLYSORBATE 806OZP39ZG8HIACT
CHOLESTEROL97C5T2UQ7JIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HORSE CHESTNUT3C18L6RJAZIACT
ASIAN GINSENGCUQ3A77YXIIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
ROSEMARYIJ67X351P9IACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
HELICHRYSUM ITALICUM FLOWERP62Y550X24IACT
HYALURONATE SODIUMYSE9PPT4THIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
62025-09-30full-release2026-06-01 01:15:21

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
40079b30-9401-2783-e063-6394a90acd0bd92f22a7-c0b5-d8b8-e053-2a95a90a23762025-09-30WarningsExact identifier
spl set id: d92f22a7-c0b5-d8b8-e053-2a95a90a2376

Reported adverse events (FAERS/openFDA)#

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