Ariella Hemorrhoid Gel

Manufacturer
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
Effective date
2024-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:59:45

Label at a glance#

ProductAriella Hemorrhoid Gel
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, LIDOCAINE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts Drug FactsDrug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients Purpose

Lidocaine 6% ………………………….………...….Protectant Phenylephrine HCL 0.25%…………………………………………….……………………..Vasoconstrictor

OTC - PURPOSE SECTION

Uses

-helps relieve itching and discomfort associated with hemorrhoids - temporarily shrinks swelling and relieves burning and pain -soothes and protects irritated tissue

DOSAGE & ADMINISTRATION SECTION

For external and/or intrarectal use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

-heart disease -high blood pressure - thyroid disease - diabetes -difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

OTC - WHEN USING SECTION

When using this product do not exceed the recommended daily dosage unless directed by a doctor

OTC - ASK DOCTOR SECTION

Stop and ask a doctor if - bleeding occurs -condition worsens or does not improve within 7 days -introduction of the applicator into the rectum causes additional pain -an allergic reaction occurs - symptom does not improve or if redness, irritation, swelling, pain or other symptoms develop or increase

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away. (1-800-222-1222)

WARNINGS SECTION

Warnings

INDICATIONS & USAGE SECTION

Directions

-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 a soft cloth before application.

-apply half the gel in the applicator to the external affected area (only applies if you have external symptoms)

-find a comfortable position and gently insert about ½ inch into the rectum.

-push the end of the applicator to apply the remaining gel inside the rectum (Both steps are necessary for both internal and external symptoms as external hemorrhoid often comes with internal hemorrhoid)

-dispose the applicator after use.

-avoid movement for 1-3 hours

-Children under 12 years of age: ask a doctor

OTHER SAFETY INFORMATION

Other information store at 15-25°C (59-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

Borneol, Carbomer Homopolymer, Chlorhexidine Acetate, Glycerin, Thymol

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83364-007ARIELLA HEMORRHOID GEL (LIDOCAINE, PHENYLEPHRINE HCL) OINTMENT [YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD]1Unmatched20240703_1bbf56f2-2f71-601b-e063-6294a90a6e99.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83364-00783364-007-01
84010-001

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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
3842bbaf-dbd2-0fb2-e063-6394a90a65dd1bbf56f2-2f71-601b-e063-6294a90a6e992025-06-23WarningsExact identifier
spl set id: 1bbf56f2-2f71-601b-e063-6294a90a6e99

Reported adverse events (FAERS/openFDA)#

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