FDA.reportPublic FDA data

Doctor Butler Advanced Formula Ointment

Manufacturer
Beyond Health, PA
Effective date
2025-07-23
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:08:29

Label at a glance#

ProductDoctor Butler Hemorrhoid and Fissure Advanced Formula
Active ingredientGLYCERIN, LIDOCAINE, LANOLIN, ZINC OXIDE
Label structure8 sections

Indications and uses

helps relieve the local or anorectal itching and discomfort associated with hemorrhoids

Dosage and administration

adults; when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before appying the ointment apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement children under 12 years of age consult your pediatrician

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 37.5%

Lanolin 12.5%

Lidocaine 4.0%

Zinc Oxide 5.0%

Purpose

OTC - PURPOSE SECTION

Protectant

Protectant

Analgesic (pain relief)

Astringent

Uses

INDICATIONS & USAGE SECTION

  • helps relieve the local or anorectal itching and discomfort associated with hemorrhoids

Warnings

WARNINGS SECTION

For external use only inclluding the skin of the anal canal

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily 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

  • condition worsens or does not improve within seven (7) days
  • bleeding occurs
  • an allergic reaction develops
  • the 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 Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults; when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before appying the ointment
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age consult your pediatrician

Other information

SPL UNCLASSIFIED SECTION

  • store at 15º-30º C (59º-86º F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aesculus Hippocastanum (Horse Chestnut) Extract

Argania Spinosa Kernel Oil

Calendula Officinalis Flower Extract

Camellia Sinensis Leaf Extract

Cananga Odorata Flower Oil (organic)

Canola Oil

Caprylic/Capric Triglyceride

Centella Asiatica Extract

Chamomilla Recutita (Matricaria) Flower Extract

Cocos Nucifera (Coconut) Oil

Curcuma Longa (Turmeric) Root Extract

Dunaliella Salina Extract

Euphorbia Cerifera (Candelilla) Wax

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 (organic)

Polyhydroxystearic Acid

Punica Granatum Fruit Extract

Ricinus Communis (Castor) Seed Oil

Rosa Canina Seed Oil (organic)

Sodium Hyaluronate

Tocopheryl Acetate

Triethoxycaprylylsilane

Viburnum Opulus Bark Extract

Water

0.75oz / 21.3g tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdppdp

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2586855glycerin 37.5 % / lanolin 12.5 % / lidocaine 4 % / zinc oxide 5 % Topical OintmentPSN5
2586855glycerin 0.375 MG/MG / lanolin 0.125 MG/MG / lidocaine 0.04 MG/MG / zinc oxide 0.05 MG/MG Topical OintmentSCD5
2586855glycerin 0.375 MG/MG / lanolin 0.125 MG/MG / lidocaine 0.04 MG/MG / ZNO 0.05 MG/MG Topical OintmentSY5
2586855glycerin 37.5 % / lanolin 12.5 % / lidocaine 4 % / zinc oxide 5 % Topical or Intrarectal OintmentSY5

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
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b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70942-517-00Doctor Butler Hemorrhoid and FissureAdvanced Formula42.5 g in 1 TUBEOINTMENT42.55
70942-517-01Doctor Butler Hemorrhoid and FissureAdvanced Formula1 in 1 CARTONOINTMENT15
70942-517-07Doctor Butler Hemorrhoid and FissureAdvanced Formula21.3 g in 1 TUBEOINTMENT21.35
70942-517-75Doctor Butler Hemorrhoid and FissureAdvanced Formula1 in 1 CARTONOINTMENT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70942-517-75GM - Gram70942-51774d85261-c665-4253-a65e-66ae1f7b304b12025-09-12

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70942-51770942-517-00, 70942-517-01, 70942-517-07, 70942-517-75

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
GREEN TEA LEAFW2ZU1RY8B0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
HYALURONATE SODIUMYSE9PPT4THIACT
VIBURNUM OPULUS WHOLEDIO510WJ04IACT
WATER059QF0KO0RIACT
ASIAN GINSENGCUQ3A77YXIIACT
AVOCADO OIL6VNO72PFC1IACT
POMEGRANATE56687D1Z4DIACT
CANDELILLA WAXWL0328HX19IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HYDROCORTISONEWI4X0X7BPJIACT
CASTOR OILD5340Y2I9GIACT
ROSA CANINA SEED OILMHT97MG5P8IACT
MACADAMIA OIL515610SU8CIACT
OLIVE OIL6UYK2W1W1EIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POGOSTEMON CABLIN LEAF OILF3IN55X5POIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
SUNFLOWER OIL3W1JG795YIIACT
LAVENDER OILZBP1YXW0H8IACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
LINSEED OIL84XB4DV00WIACT
COCONUT OILQ9L0O73W7LIACT
CHAMOMILEFGL3685T2XIACT
CANOLA OIL331KBJ17RKIACT
CANANGA OIL8YOY78GNNXIACT
HORSE CHESTNUT3C18L6RJAZIACT
TURMERIC856YO1Z64FIACT
ARGAN OIL4V59G5UW9XIACT
DUNALIELLA SALINAF4O1DKI9A6IACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX42DG15CHXVIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GLYCERINPDC6A3C0OXACTIB
LIDOCAINE98PI200987ACTIB
LANOLIN7EV65EAW6HACTIB
ZINC OXIDESOI2LOH54ZACTIB

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 Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
ndc (package): 70942-517-75
ndc (package): 70942-517-07
ndc (package): 70942-517-00
ndc (package): 70942-517-01
ndc (product): 70942-517
ndc11 (package): 70942051701
ndc11 (package): 70942051707
ndc11 (package): 70942051775
ndc11 (package): 70942051700
spl id: 3a9b3c55-04fb-8c74-e063-6294a90a0de8
spl set id: d2a769e2-afd0-aed2-e053-2995a90ad429

Reported adverse events (FAERS/openFDA)#

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