Ariella Hemorrhoid Gel
FDA Label NDC 83364-002

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 83364-002). 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 active ingredient                               purpose, uses, warnings, directions, other information, inactive ingredients, questions or comments?, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                               Purpose

Cortex Phellodendri  6%                        Protectant

Acacia Catechu Wood Extract  2%          Protectant

Sophora Flavescens Root Extract 12%    Vasoconstrictor

Uses

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

Warnings

For external use only.

Ask a doctorbefore 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)

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

Calamine, Daemonorops Draco Extract, Mentholatum, Glycyrrhiza Glabra, Aqua, Alcohol, Carbomer, Triethanolamine, Ethylparaben

* Please review the disclaimer below.