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
Dr Butler Hemorrhoid & Fissure Ointment PF
- Manufacturer
- Beyond Health P.A.
- Effective date
- 2026-10-22
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-10-27 02:01:49
Label at a glance#
ProductDr Butlers Hemorrhoid and Fissure PF
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections
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
Lidocaine USP 4%
Phenylephrine HCl 0.25%
Purpose
Analgesic (pain relief)
Vasoconstrictor
Uses
- temporarily shrinks hemorrhoidal tissue
- for the temporary relief of pain, soreness, or burning
- helps relieve the local itching and discomfort associated with hemorrhoids
Warnings
For external use only including the skin of the anal canal.
When using this product
- 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
- 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
- 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
as a health care professional before use.
Keep out of reach of children
if swallowed, seek medical help or contact a Poison Control Center right away.
Directions
- 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
- store at 15º-30º C (59º-86º F)
Inactive Ingedients
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
Carton of 12 0.07oz / 2g packets
DailyMed Product Concepts#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70942-357-07 | GM - Gram | 70942-357 | 33bcdb8c-dc7c-460c-88a9-a08b3eb6ecfc | 1 | 2025-11-13 |
| 70942-357-75 | GM - Gram | 70942-357 | 3b213a17-51e1-483f-ad34-8d8d9712ebff | 1 | 2025-09-12 |
Products#
Every source-derived product name is available through these pages.
- Dr Butlers Hemorrhoid and Fissure PF
- Lidocaine 4.00, Phenylephrine Hydrochloride 0.25
- LIDOCAINE
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- HORSE CHESTNUT
- ALOE
- ASCORBIC ACID
- CALENDULA OFFICINALIS FLOWER
- CAPRYLHYDROXAMIC ACID
- CENTELLA ASIATICA
- CHOLECALCIFEROL
- SUNFLOWER OIL
- HYDROCORTISONE
- LYSINE HYDROCHLORIDE
- MINERAL OIL
- CAPRYLIC/CAPRIC TRIGLYCERIDE
- OLIVE OIL
- ASIAN GINSENG
- MATRICARIA CHAMOMILLA FLOWERING TOP OIL
- PETROLATUM
- PROPYLENE GLYCOL
- PUNICA GRANATUM ROOT BARK
- GLYCERYL CAPRYLATE
- VITAMIN A PALMITATE
- LAMINARIA DIGITATA
- HYALURONATE SODIUM
- PORPHYRA UMBILICALIS
- STEARIC ACID
- .ALPHA.-TOCOPHEROL ACETATE
- TRIETHOXYCAPRYLYLSILANE
- WATER
- GLYCERIN
- ZINC OXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70942-357 | 70942-357-00, 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.
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-11-26 | full-release | 2026-06-01 01:18:19 |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 44848a07-eb1f-3040-e063-6294a90a1762 | f526199e-5c9e-7a3c-e053-2a95a90aa98e | 2025-11-26 | Warnings | f526199e-5c9e-7a3c-e053-2a95a90aa98e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.