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)
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']}