HEALSURE HEMORRHOID FISSURE

Manufacturer
Jiangxi Hemei Pharmaceutical Co., Ltd
Effective date
2025-05-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:39:17

Label at a glance#

ProductHEALSURE HEMORRHOID FISSURE
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure13 sections

Dosage and administration

Children under 12 years of age should consult their pediatrician. Adults: apply to affected area up to 3 times daily.Clean 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 gently insert part way into anus and squeeze tube to deliver medication. Thoroughly clean...

Storage and handling

If pregnant or breast-feeding, ask a health care professional before use.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Phenylephrine HCL 0.25%

Purpose

OTC - PURPOSE SECTION

Analgesic (pain relief) Vasoconstrictor

Use

INDICATIONS & USAGE SECTION

Temporarily shrink hemorrhoidal tissue, relieving pain,soreness, burning, itching, anddiscomfort associated with hemorrhoids.

Warnings

WARNINGS SECTION

For external use only, including the skin aroundthe anal canal

Do not use

OTC - DO NOT USE SECTION

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, or presently taking a prescription for high blood pressure or depression.

When Using

OTC - WHEN USING SECTION

When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only.

Stop Use

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or does not improve
within seven 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.

Ask Doctor

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if condition worsens or does not improve
within seven 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.

Keep Oot 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 should consult their pediatrician. Adults: apply to affected area up to 3 times daily.Clean 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 gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

Other information

STORAGE AND HANDLING SECTION

If pregnant or breast-feeding, ask a health care professional before use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Borneol,Carbomer Homopolymer,Chlorhexidine Acetate, Glycerin, Thymol, Aloe

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84010-107HEALSURE HEMORRHOID FISSURE (LIDOCAINE 4%, PHENYLEPHRINE HCL 0.25%, HEMORRHOID FISSURE) OINTMENT [JIANGXI HEMEI PHARMACEUTICAL CO., LTD]1Unmatched20250507_3474ac7d-7eb2-55ce-e063-6294a90af5e4.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84010-10784010-107-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

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
4a4b9507-b5df-c08a-e063-6294a90a185f3474ac7d-7eb2-55ce-e063-6294a90af5e42026-02-08WarningsExact identifier
spl set id: 3474ac7d-7eb2-55ce-e063-6294a90af5e4

Reported adverse events (FAERS/openFDA)#

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