Ariella Hemorrhoid Gel

Ariella Hemorrhoid Gel
SPL v1
SPL
SPL Set ID 969c5525-b54e-4de2-a5b7-14be9cc112fc
Route
TOPICAL
Published
Effective Date 2025-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (0.25 g) Lidocaine (4 g)
Inactive Ingredients
Borneol Carbomer Homopolymer, Unspecified Type Glycerin Chlorhexidine Acetate Thymol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-24

Description

Drug Facts


Medication Information

Warnings and Precautions

Warnings

Indications and 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

Dosage and Administration

For external and/or intrarectal use only

Description

Drug Facts

Section 50565-1

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)

Section 50567-7

When using this product do not exceed the recommended daily dosage unless directed by a doctor

Section 50568-5

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Section 50569-3

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

Section 51727-6

Inactive ingredients

Borneol, Carbomer Homopolymer, Chlorhexidine Acetate, Glycerin, Thymol

Section 51945-4

Drug Facts

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

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

Section 55106-9

Active ingredients Purpose

Lidocaine 6% ………………………….………...….Protectant Phenylephrine HCL 0.25%…………………………………………….……………………..Vasoconstrictor

Section 60561-8

Other information store at 15-25°C (59-77°F)


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

For external and/or intrarectal use only

Warnings and Precautions (34071-1)

Warnings

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product do not exceed the recommended daily dosage unless directed by a doctor

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

Section 50569-3 (50569-3)

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

Section 51727-6 (51727-6)

Inactive ingredients

Borneol, Carbomer Homopolymer, Chlorhexidine Acetate, Glycerin, Thymol

Section 51945-4 (51945-4)

Drug Facts

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

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

Section 55106-9 (55106-9)

Active ingredients Purpose

Lidocaine 6% ………………………….………...….Protectant Phenylephrine HCL 0.25%…………………………………………….……………………..Vasoconstrictor

Section 60561-8 (60561-8)

Other information store at 15-25°C (59-77°F)


Advanced Ingredient Data


Raw Label Data

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