Package Label.Principal Display Panel
Drug Facts
Ariella Hemorrhoid Gel
FDA Label NDC 83364-022
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yitongbada (shenzhen) International Trade Co., Ltd for the product Ariella Hemorrhoid Gel (NDC 83364-022). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding package label.principal display panel, otc - active ingredient, dosage & administration, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients Purpose
Lidocaine 6% ………………………….………...….Protectant Phenylephrine HCL 0.25%…………………………………………….……………………..Vasoconstrictor
Dosage & Administration
For external and/or intrarectal use only
Otc - Ask Doctor
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
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 - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.
Otc - When Using
When using this product do not exceed the recommended daily dosage unless directed by a doctor
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
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)
Otc - Purpose
Uses
-helps relieve itching and discomfort associated with hemorrhoids - temporarily shrinks swelling and relieves burning and pain -soothes and protects irritated tissue
Warnings
Warnings
Indications & Usage
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
Inactive ingredients
Borneol, Carbomer Homopolymer, Chlorhexidine Acetate, Glycerin, Thymol
* Please review the disclaimer below.
