Ariella Hemorrhoid Gel — v1

Ariella Hemorrhoid Gel

3 Views

Version

v1

Effective date

September 24, 2025

Original packager

Sections captured

14

Identifiers

Document ID
3f9132a2-501c-bee7-e063-6394a90a19cd
Set ID
969c5525-b54e-4de2-a5b7-14be9cc112fc
Application numbers
M005
Product NDCs
83364-022
Package NDCs
83364-022-01
Original packager NDCs
84010-001

Names & Manufacturers

Brand names
Ariella Hemorrhoid Gel
Generic names
LIDOCAINE, PHENYLEPHRINE HCL
Manufacturer names
YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
Product types
HUMAN OTC DRUG

Substances & Pharmacology

Substance names
LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Routes
TOPICAL
Pharmacologic class (PE)
Local Anesthesia [PE]
Pharmacologic class (EPC)
Amide Local Anesthetic [EPC], Antiarrhythmic [EPC]
Pharmacologic class (CS)
Amides [CS]
Mechanism of action

Other identifiers

NUI
M0000897, N0000175426, N0000175682, N0000175976
RxCUI
UNII
04JA59TNSJ, 98PI200987
UPC

Structured Label Sections

Active Ingredient (1)

Sequence 1

Active ingredients Purpose Lidocaine 6% ………………………….………...….Protectant Phenylephrine HCL 0.25%…………………………………………….……………………..Vasoconstrictor For external and/or intrarectal use only 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 Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor 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 If pregnant or breast-feeding, ask a health professional before use. 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)
Ask Doctor (2)

Sequence 1

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

Sequence 2

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
Ask Doctor Or Pharmacist (1)

Sequence 1

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
Dosage And Administration (1)

Sequence 1

For external and/or intrarectal use only
Inactive Ingredient (1)

Sequence 1

Inactive ingredients Borneol, Carbomer Homopolymer, Chlorhexidine Acetate, Glycerin, Thymol
Indications And Usage (1)

Sequence 1

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
Keep Out Of Reach Of Children (1)

Sequence 1

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)
Other Safety Information (1)

Sequence 1

Other information store at 15-25°C (59-77°F)
Package Label Principal Display Panel (1)

Sequence 1

Drug Facts Drug Facts Active ingredients Purpose Lidocaine 6% ………………………….………...….Protectant Phenylephrine HCL 0.25%…………………………………………….……………………..Vasoconstrictor For external and/or intrarectal use only 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 Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression. When using this product do not exceed the recommended daily dosage unless directed by a doctor 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 If pregnant or breast-feeding, ask a health professional before use. 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) Uses -helps relieve itching and discomfort associated with hemorrhoids - temporarily shrinks swelling and relieves burning and pain -soothes and protects irritated tissue Warnings 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 information store at 15-25°C (59-77°F) Inactive ingredients Borneol, Carbomer Homopolymer, Chlorhexidine Acetate, Glycerin, Thymol
Pregnancy Or Breast Feeding (1)

Sequence 1

If pregnant or breast-feeding, ask a health professional before use.
Purpose (1)

Sequence 1

Uses -helps relieve itching and discomfort associated with hemorrhoids - temporarily shrinks swelling and relieves burning and pain -soothes and protects irritated tissue
Spl Product Data Elements (1)

Sequence 1

Ariella Hemorrhoid Gel Lidocaine, Phenylephrine HCL BORNEOL CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE GLYCERIN CHLORHEXIDINE ACETATE THYMOL PHENYLEPHRINE HYDROCHLORIDE PHENYLEPHRINE LIDOCAINE LIDOCAINE
Warnings (1)

Sequence 1

Warnings
When Using (1)

Sequence 1

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

OpenFDA raw payload

{'application_number': ['M005'],
 'brand_name': ['Ariella Hemorrhoid Gel'],
 'generic_name': ['LIDOCAINE, PHENYLEPHRINE HCL'],
 'manufacturer_name': ['YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD'],
 'nui': ['N0000175682', 'M0000897', 'N0000175426', 'N0000175976'],
 'original_packager_product_ndc': ['84010-001'],
 'package_ndc': ['83364-022-01'],
 'pharm_class_cs': ['Amides [CS]'],
 'pharm_class_epc': ['Amide Local Anesthetic [EPC]', 'Antiarrhythmic [EPC]'],
 'pharm_class_pe': ['Local Anesthesia [PE]'],
 'product_ndc': ['83364-022'],
 'product_type': ['HUMAN OTC DRUG'],
 'route': ['TOPICAL'],
 'spl_id': ['3f9132a2-501c-bee7-e063-6394a90a19cd'],
 'spl_set_id': ['969c5525-b54e-4de2-a5b7-14be9cc112fc'],
 'substance_name': ['LIDOCAINE', 'PHENYLEPHRINE HYDROCHLORIDE'],
 'unii': ['98PI200987', '04JA59TNSJ']}