ARIELLA HEMORRHOID- lidocaine, phenylephrine hcl ointment

Ariella Hemorrhoid by

Drug Labeling and Warnings

Ariella Hemorrhoid by is a Otc medication manufactured, distributed, or labeled by YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

Drug Facts

Active ingredients Purpose

Lidocaine 6% ………………………….………………………………………………………...….Protectant

Phenylephrine HCL 0.25%…………………………………………….……………………..Vasoconstrictor

Lidocaine 6% ………………………….………………………………………………………...….Protectant

Phenylephrine HCL 0.25%…………………………………………….……………………..Vasoconstrictor

Uses

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

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)

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

INGREDIENTS AND APPEARANCE

ARIELLA HEMORRHOID 
lidocaine, phenylephrine hcl ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83364-012(NDC:84010-001)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	0.25 g  in 100 g
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
BORNEOL (UNII: M89NIB437X)
CHLORHEXIDINE ACETATE (UNII: 5908ZUF22Y)
GLYCERIN (UNII: PDC6A3C0OX)
THYMOL (UNII: 3J50XA376E)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83364-012-01	6 in 1 BOX	11/01/2024
1		3 g in 1 APPLICATOR; Type 0: Not a Combination Product
2	NDC: 83364-012-02	12 in 1 BOX	11/01/2024
2		3 g in 1 APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	11/01/2024

Labeler - YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD (725220463)