SPL v2
SPL
SPL Set ID 3c4eaba1-9612-c130-e063-6394a90a3616
Route
TOPICAL
Published
Effective Date 2025-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sophora Flavescens Root (15 g) Phellodendrine
Inactive Ingredients
Cnidium Monnieri Fruit Stephania Japonica Whole Artemisia Argyi Leaf Water Carthamus Tinctorius Flower Oil Carboplatin Lavandula Angustifolia Whole Wolfiporia Cocos Whole Borneol Chlorhexidine Diacetate Glycerin Methyl Paraoxon Cupric Triethanolamine Aloe Bassia Scoparia Whole

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-02-01

Description

Phellodendri chinensis Cortex 15%--------Swelling & Pain Relief Sophora Flavescens Root15%---------Anti-Inflammatory

Dosage and Administration

Use 2 to 3 times a day, one application per dose. When practical, cleanse the affected area with mild soap and warmwater, rinse thoroughly.Dry the area by gently patting or blotting witha tissue or soft cloth before application. Apply half of the gel in the applicator to the external affected area ifexterna symptoms are present.


Medication Information

Dosage and Administration

Use 2 to 3 times a day, one application per dose.

When practical, cleanse the affected area with mild soap and warmwater, rinse thoroughly.Dry the area by gently patting or blotting witha tissue or soft cloth before application.

Apply half of the gel in the applicator to the external affected area ifexterna symptoms are present.

Description

Phellodendri chinensis Cortex 15%--------Swelling & Pain Relief Sophora Flavescens Root15%---------Anti-Inflammatory

Uses

·Helps relieve itching and discomfort associated with hemorrhoids.

·Temporarily shrinks hemorrhoids and relieves burning and pain.

. Soothes and protects irritated tissue.

Lable

Stop Use

Bleeding occurs and an allergic reaction develops.

Condition worsens or does not improve within 7 days.

Introduction of the applicator into the rectum causes additional pain.

Symptoms do not improve, or if redness, irritation, swelling, pain, orother symptoms develop or worsen.

Warnings

For external and / or intra-rectal use only.

Directions:

Use 2 to 3 times a day, one application per dose.

When practical, cleanse the affected area with mild soap and warmwater, rinse thoroughly.Dry the area by gently patting or blotting witha tissue or soft cloth before application.

Apply half of the gel in the applicator to the external affected area ifexterna symptoms are present.

Ask A Doctor

Heart disease, High blood pressure, Thyroid disease, and Diabetes Difficulty in urination due to enlargement of the prostate gland.

Other Information

Store at room temperature 15-25°C(59-77°F)

Active Ingredients

Phellodendri chinensis Cortex 15%--------Swelling & Pain Relief

Sophora Flavescens Root15%---------Anti-Inflammatory

Inactive Ingredients

Common Cnidium Fruit, Stephania Japonica (Thunb.) Miers, Belvedere Fruit,Artemisia Argyi Leaf Extract, Carthami Flos, Poria, Aloe, LavandulaAngustifolia Extract, Borneol, Glycerin, Methylparaben, Carbopol,Triethanolamine,Chlorhexidine Diacetate, Purified Water.

When Using This Product

Do not exceed the recommended daily dosage unless directed by a

doctor.

Keep Out of Reach of Children

If swallowed, call a poison control center or seek medical attention immediately.


Structured Label Content

Uses

·Helps relieve itching and discomfort associated with hemorrhoids.

·Temporarily shrinks hemorrhoids and relieves burning and pain.

. Soothes and protects irritated tissue.

Lable

Stop Use (Stop use)

Bleeding occurs and an allergic reaction develops.

Condition worsens or does not improve within 7 days.

Introduction of the applicator into the rectum causes additional pain.

Symptoms do not improve, or if redness, irritation, swelling, pain, orother symptoms develop or worsen.

Warnings

For external and / or intra-rectal use only.

Directions:

Use 2 to 3 times a day, one application per dose.

When practical, cleanse the affected area with mild soap and warmwater, rinse thoroughly.Dry the area by gently patting or blotting witha tissue or soft cloth before application.

Apply half of the gel in the applicator to the external affected area ifexterna symptoms are present.

Ask A Doctor (Ask a doctor)

Heart disease, High blood pressure, Thyroid disease, and Diabetes Difficulty in urination due to enlargement of the prostate gland.

Other Information (Other information)

Store at room temperature 15-25°C(59-77°F)

Active Ingredients (Active ingredients)

Phellodendri chinensis Cortex 15%--------Swelling & Pain Relief

Sophora Flavescens Root15%---------Anti-Inflammatory

Inactive Ingredients

Common Cnidium Fruit, Stephania Japonica (Thunb.) Miers, Belvedere Fruit,Artemisia Argyi Leaf Extract, Carthami Flos, Poria, Aloe, LavandulaAngustifolia Extract, Borneol, Glycerin, Methylparaben, Carbopol,Triethanolamine,Chlorhexidine Diacetate, Purified Water.

When Using This Product (When using this product)

Do not exceed the recommended daily dosage unless directed by a

doctor.

Dosage and Administration (Dosage and administration)

Use 2 to 3 times a day, one application per dose.

When practical, cleanse the affected area with mild soap and warmwater, rinse thoroughly.Dry the area by gently patting or blotting witha tissue or soft cloth before application.

Apply half of the gel in the applicator to the external affected area ifexterna symptoms are present.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, call a poison control center or seek medical attention immediately.


Advanced Ingredient Data


Raw Label Data

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