85248-018update

Manufacturer
Jiangxi Yudexi Pharmaceutical Co., LTD
Effective date
2026-06-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
daily-update
Hydrated at
2026-06-16 05:10:13

Label at a glance#

ProductDr.Seymour Butts Hemorrhoid
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Dosage and administration

Adults: When practical, cleanse the affected area with mild soap and warm water, rinse thoroughly, and gently dry. Apply to the affected area up to 4 times daily, especially at night, in the morning, and after each bowel movement. To use applicator: lubricate applicator; gently insert partway into the anal canal and apply a small amount. Clean applicator after each use. Children under 12 years of age: ask a doctor.

Storage and handling

Store at 20–25°C (68–77°F).

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% Phenylephrine HCl 0.25%

Purpose

OTC - PURPOSE SECTION

Local anesthetic,Vasoconstrictor

Use

INDICATIONS & USAGE SECTION

Temporarily shrinks hemorrhoidal tissue and relieves pain, soreness,
burning, itching, and discomfort associated with hemorrhoids.

Warnings

WARNINGS SECTION

For external use only Allergy alert: do not use if you have a history of allergy to amide-type
local anesthetics (e.g., lidocaine).

Do not use

OTC - DO NOT USE SECTION

• if the tube seal is broken or missing • in children under 12 years of age
unless directed by a doctor • for more than 7 days unless directed by a
doctor

When Using

OTC - WHEN USING SECTION

• avoid contact with eyes • do not exceed the recommended dosage
unless directed by a doctor • do not put this product into the rectum (use
the applicator as directed) • if introduction of applicator causes additional
pain, stop use and ask a docto

Stop Use

OTC - STOP USE SECTION

• bleeding occurs • condition worsens or does not improve within 7 days
• redness, irritation, swelling, pain, or rash develops
If pregnant or breast-feeding, ask a health professional before use.

Ask Doctor

OTC - ASK DOCTOR SECTION

• heart disease, high blood pressure, thyroid disease, or diabetes •
difficulty urinating due to an enlarged prostate • allergies to amide-type
local anesthetics

Keep Oot Of Reach Of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults: When practical, cleanse the affected area with mild soap and
warm water, rinse thoroughly, and gently dry. Apply to the affected area
up to 4 times daily, especially at night, in the morning, and after each
bowel movement. To use applicator: lubricate applicator; gently insert
partway into the anal canal and apply a small amount. Clean applicator
after each use.
Children under 12 years of age: ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at 20–25°C (68–77°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Purified Water,Witch Hazel Extract, Aloe Vera Extract, Boswellia serrata Extract, Sophora,
japonica Extract, Calendula Extract, Centella asiatica Extract, Vitamin E
(Tocopherol), Tocopheryl Acetate, Petrolatum USP, Shea Butter, Glycerin,
Caprylic/Capric Triglycerides (MCT), Cetearyl Alcohol, Glyceryl Stearate,
PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

55

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codedrseymourbutts.com/ca8458f338d68397eb8d3788f08c5deb.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85248-01885248-018-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-29full-release2026-06-01 01:35:27

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.Seymour Butts HemorrhoidLIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4981c7d9-53ee-2a7b-e063-6394a90add012026-06-12WarningsExact identifier
ndc (package): 85248-018-01
ndc (product): 85248-018
ndc11 (package): 85248001801
spl id: 540b049a-285a-e120-e063-6294a90a8a93
spl set id: 4981c7d9-53ee-2a7b-e063-6394a90add01

Reported adverse events (FAERS/openFDA)#

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