84735-008 Liposomal Hemorrhoid Master

84735-008 Liposomal Hemorrhoid Master
SPL v1
SPL
SPL Set ID 34eb651c-abf3-f334-e063-6294a90a6f01
Route
TOPICAL
Published
Effective Date 2025-05-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Phenylephrine (0.25 g)
Inactive Ingredients
Propylene Glycol Sodium Hyaluronate Pyridoxine Hcl Chamomile Phenoxyethanol Water Glycerin Ascorbic Acid Triethanolamine Aloe Barbadensis Leaf Mineral Oil Tocopherol Dexpanthenol Allantoin Ethylhexylglycerin Carbomer Petrolatum Asian Ginseng Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-12

Description

Lidocaine HCl 4% Phenylephrine HCl 0.25%


Medication Information

Warnings and Precautions

For external and /or intrarectal use only.

Indications and Usage



Uses. Forthe temporany relief of local and anorectal iching and discomfot asociated with anoreclal isorders and anorectalimammation.

Forthe temporany reief of pain,buring and sorenes.

Temporarily shrinks hemorthoidal tisue, Temporarily reduces the sweling associated with iritation in hemorthoids and other anorectal disorders.

Dosage and Administration

Directions: Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.

Description

Lidocaine HCl 4% Phenylephrine HCl 0.25%

Section 50565-1

Keep away from direct sunlight or heat.

Section 50566-9

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Section 50567-7



If condition worsens or does not improve within 7 days, consult a doctor.

Do not exceed the recommended daily dosage unless directed by a doctor.

In case of bleeding, consult a doctor promptly.

Section 50570-1



Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

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

Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

Section 51727-6

Petrolatum

Aloe Barbadensis Leaf Extract

Glycerin

Mineral Oil

Chamomilla Recutita (Matricaria) Flower Extract

Tocopherol

Ascorbic Acid

Pyridoxine HCl

Ginseng Extract

Propylene Glycol

Sodium Hyaluronate

Polysorbate 80

Panthenol

Allantoin

Phenoxyethanol

Ethylhexylglycerin

Carbomer

Triethanolamine

Water

Section 51945-4

Section 55105-1



Loca Anesthetic

Vasoconstrictor

Section 55106-9

Lidocaine HCl 4%

Phenylephrine HCl 0.25%


Structured Label Content

Indications and Usage (34067-9)



Uses. Forthe temporany relief of local and anorectal iching and discomfot asociated with anoreclal isorders and anorectalimammation.

Forthe temporany reief of pain,buring and sorenes.

Temporarily shrinks hemorthoidal tisue, Temporarily reduces the sweling associated with iritation in hemorthoids and other anorectal disorders.

Dosage and Administration (34068-7)

Directions: Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

For external and /or intrarectal use only.

Section 50565-1 (50565-1)

Keep away from direct sunlight or heat.

Section 50566-9 (50566-9)

Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

Section 50567-7 (50567-7)



If condition worsens or does not improve within 7 days, consult a doctor.

Do not exceed the recommended daily dosage unless directed by a doctor.

In case of bleeding, consult a doctor promptly.

Section 50570-1 (50570-1)



Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

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

Do not use this product with an applicator if the introduction of the applicator into the rectum causes additional pain. Consult a doctor promptly.

Section 51727-6 (51727-6)

Petrolatum

Aloe Barbadensis Leaf Extract

Glycerin

Mineral Oil

Chamomilla Recutita (Matricaria) Flower Extract

Tocopherol

Ascorbic Acid

Pyridoxine HCl

Ginseng Extract

Propylene Glycol

Sodium Hyaluronate

Polysorbate 80

Panthenol

Allantoin

Phenoxyethanol

Ethylhexylglycerin

Carbomer

Triethanolamine

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)



Loca Anesthetic

Vasoconstrictor

Section 55106-9 (55106-9)

Lidocaine HCl 4%

Phenylephrine HCl 0.25%


Advanced Ingredient Data


Raw Label Data

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