Label: ARIELLA HEMORRHOID GEL- phellodendron chinense whole,senegalia catechu wood,sophora flavescens root gel

  • NDC Code(s): 83364-002-01
  • Packager: YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 11, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient                               Purpose

    Cortex Phellodendri  6%                        Protectant

    Acacia Catechu Wood Extract  2%          Protectant

    Sophora Flavescens Root Extract 12%    Vasoconstrictor

  • PURPOSE

  • 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)

  • KEEP OUT OF REACH OF CHILDREN

  • 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

  • Questions or comments?

    Contact us at www.tryariella.com or email cs@tryariella.com

  • Product label

    image descriptionimage description

  • INGREDIENTS AND APPEARANCE
    ARIELLA HEMORRHOID GEL 
    phellodendron chinense whole,senegalia catechu wood,sophora flavescens root gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83364-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHELLODENDRON CHINENSE WHOLE (UNII: QKA3ZK8IIE) (PHELLODENDRON CHINENSE WHOLE - UNII:QKA3ZK8IIE) PHELLODENDRON CHINENSE WHOLE6 g  in 100 g
    SENEGALIA CATECHU WOOD (UNII: CHL342Y4LA) (SENEGALIA CATECHU WOOD - UNII:CHL342Y4LA) SENEGALIA CATECHU WOOD2 g  in 100 g
    SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K) (SOPHORA FLAVESCENS ROOT - UNII:IYR6K8KQ5K) SOPHORA FLAVESCENS ROOT12 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    CALAMUS DRACO WHOLE (UNII: 1C8HA8O22C)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83364-002-016 in 1 BOX05/17/2023
    13 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/17/2023
    Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)