FDA.reportPublic FDA data

Dr Butler Hemorrhoid & Fissure Ointment PF

Manufacturer
Beyond Health P.A.
Effective date
2025-11-26
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:18:19

Label at a glance#

ProductDr Butlers Hemorrhoid and Fissure PF
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Indications and uses

temporarily shrinks hemorrhoidal tissue for the temporary relief of pain, soreness, or burning helps relieve the local itching and discomfort associated with hemorrhoids

Dosage and administration

children under 12 years of age consult your pediatrician. adults: apply to affected area up to 4 times daily. cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use. to use dispensing cap, attach it to tube, lubricate well, then apply externally to the skin of the anal canal only. Thoroughly cleanse dispensing cap af...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine USP 4%

Phenylephrine HCl 0.25%

Purpose

OTC - PURPOSE SECTION

Analgesic (pain relief)

Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • temporarily shrinks hemorrhoidal tissue
  • for the temporary relief of pain, soreness, or burning
  • helps relieve the local itching and discomfort associated with hemorrhoids

Warnings

WARNINGS SECTION

For external use only including the skin of the anal canal.

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended dosage unless directed by a doctor
  • when using finger cots or an applicator, apply externally or to the skin of the anal canal only. Do not put this product into the rectum

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • allergies to any of the components of this product
  • difficulty in urination due to enlargement of the prostate gland
  • Diabetes
  • Heart Disease
  • High Blood Pressure
  • Thyroid Disease
  • presently taking a prescription for high blood pressure or depression

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 reation 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

as 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

  • children under 12 years of age consult your pediatrician.
  • adults: apply to affected area up to 4 times daily.
  • cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.
  • to use dispensing cap, attach it to tube, lubricate well, then apply externally to the skin of the anal canal only. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly

Other Information

SPL UNCLASSIFIED SECTION

  • store at 15º-30º C (59º-86º F)

Inactive Ingedients

INACTIVE INGREDIENT SECTION

Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, olea europaea (olive) fruit oil, panax ginseng root extract, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, retinyl palmitate, sodium hyaluronate, stearic acid, tocopheryl acetate, triethoxycaprylysilane, water, zinc oxide

0.75oz / 21.3g tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp_tubepdp_tube

Carton of 12 0.07oz / 2g packets

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

pdp_packetspdp_packets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentPSN5
2673304lidocaine 0.04 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD5
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentSY5

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE 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
60c52429-fcef-eb54-2387-43bc9e4f296bProduct 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
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
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
70942-357-00Dr Butlers Hemorrhoid and Fissure PF28 g in 1 TUBEOINTMENT285
70942-357-01Dr Butlers Hemorrhoid and Fissure PF1 in 1 CARTONOINTMENT15
70942-357-05Dr Butlers Hemorrhoid and Fissure PF42.5 g in 1 TUBEOINTMENT42.55
70942-357-06Dr Butlers Hemorrhoid and Fissure PF2 g in 1 PACKETOINTMENT25
70942-357-07Dr Butlers Hemorrhoid and Fissure PF21.3 g in 1 TUBEOINTMENT21.35
70942-357-12Dr Butlers Hemorrhoid and Fissure PF12 in 1 CARTONOINTMENT125
70942-357-15Dr Butlers Hemorrhoid and Fissure PF1 in 1 CARTONOINTMENT15
70942-357-75Dr Butlers Hemorrhoid and Fissure PF1 in 1 CARTONOINTMENT15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70942-357-07GM - Gram70942-35733bcdb8c-dc7c-460c-88a9-a08b3eb6ecfc12025-11-13
70942-357-75GM - Gram70942-3573b213a17-51e1-483f-ad34-8d8d9712ebff12025-09-12

Products#

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

DailyMed product names page 1 of 1 · 34 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70942-35770942-357-00, 70942-357-01, 70942-357-07, 70942-357-75, 70942-357-06, 70942-357-12, 70942-357-05, 70942-357-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
HORSE CHESTNUT3C18L6RJAZIACT
ALOEV5VD430YW9IACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CENTELLA ASIATICA7M867G6T1UIACT
CHOLECALCIFEROL1C6V77QF41IACT
SUNFLOWER OIL3W1JG795YIIACT
HYDROCORTISONEWI4X0X7BPJIACT
LYSINE HYDROCHLORIDEJNJ23Q2COMIACT
MINERAL OILT5L8T28FGPIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
OLIVE OIL6UYK2W1W1EIACT
ASIAN GINSENGCUQ3A77YXIIACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT
PETROLATUM4T6H12BN9UIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PUNICA GRANATUM ROOT BARKCLV24I3T1DIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
LAMINARIA DIGITATA15E7C67EE8IACT
HYALURONATE SODIUMYSE9PPT4THIACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
STEARIC ACID4ELV7Z65APIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
ZINC OXIDESOI2LOH54ZIACT
LIDOCAINE98PI200987ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIM

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
Dr Butlers Hemorrhoid and Fissure PFLIDOCAINE 4.00, PHENYLEPHRINE HYDROCHLORIDE 0.25Beyond Health P.A.f526199e-5c9e-7a3c-e053-2a95a90aa98e2025-11-26WarningsExact identifier
ndc (package): 70942-357-00
ndc (package): 70942-357-12
ndc (package): 70942-357-15
ndc (package): 70942-357-75
ndc (package): 70942-357-01
ndc (package): 70942-357-07
ndc (package): 70942-357-06
ndc (package): 70942-357-05
ndc (product): 70942-357
ndc11 (package): 70942035705
ndc11 (package): 70942035701
ndc11 (package): 70942035707
ndc11 (package): 70942035775
ndc11 (package): 70942035712
ndc11 (package): 70942035706
ndc11 (package): 70942035700
ndc11 (package): 70942035715
spl id: 44848a07-eb1f-3040-e063-6294a90a1762
spl set id: f526199e-5c9e-7a3c-e053-2a95a90aa98e

Reported adverse events (FAERS/openFDA)#

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