85248-018

85248-018
SPL v1
SPL
SPL Set ID 4981c7d9-53ee-2a7b-e063-6394a90add01
Route
TOPICAL
Published
Effective Date 2026-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g) Phenylephrine (0.25 g)
Inactive Ingredients
Peg-100 Stearate Shea Butter Glyceryl Stearate Caprylic/capric Triglyceride Water Boswellia Serrata Gum Petrolatum Baptisia Alba Whole Phenoxyethanol Calendula Arvensis Leaf Cetostearyl Alcohol Aloe Vera Leaf Swertia Japonica Whole Flowering .alpha.-tocopherol Ethylhexylglycerin Centella Asiatica Triterpenoids .alpha.-tocopherol Acetate Witch Hazel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-29

Description

Lidocaine 5% Phenylephrine HCl 0.25%

Purpose

Local anesthetic,Vasoconstrictor


Medication Information

Purpose

Local anesthetic,Vasoconstrictor

Description

Lidocaine 5% Phenylephrine HCl 0.25%

Use

Temporarily shrinks hemorrhoidal tissue and relieves pain, soreness,

burning, itching, and discomfort associated with hemorrhoids.

Stop Use

• bleeding occurs • condition worsens or does not improve within 7 days

• redness, irritation, swelling, pain, or rash develops

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

Warnings

For external use only Allergy alert: do not use if you have a history of allergy to amide-type

local anesthetics (e.g., lidocaine).

Ask Doctor

• heart disease, high blood pressure, thyroid disease, or diabetes •

difficulty urinating due to an enlarged prostate • allergies to amide-type

local anesthetics

Directions

Adults: When practical, cleanse the affected area with mild soap and

warm water, rinse thoroughly, and gently dry. Apply to the affected area

up to 4 times daily, especially at night, in the morning, and after each

bowel movement. To use applicator: lubricate applicator; gently insert

partway into the anal canal and apply a small amount. Clean applicator

after each use.

Children under 12 years of age: ask a doctor.

Do Not Use

• if the tube seal is broken or missing • in children under 12 years of age

unless directed by a doctor • for more than 7 days unless directed by a

doctor

When Using

• avoid contact with eyes • do not exceed the recommended dosage

unless directed by a doctor • do not put this product into the rectum (use

the applicator as directed) • if introduction of applicator causes additional

pain, stop use and ask a docto

Active Ingredient

Lidocaine 5% Phenylephrine HCl 0.25%

Other Information

Store at 20–25°C (68–77°F).

Inactive Ingredients

Purified Water,Witch Hazel Extract, Aloe Vera Extract, Boswellia serrata Extract, Sophora,

japonica Extract, Calendula Extract, Centella asiatica Extract, Vitamin E

(Tocopherol), Tocopheryl Acetate, Petrolatum USP, Shea Butter, Glycerin,

Caprylic/Capric Triglycerides (MCT), Cetearyl Alcohol, Glyceryl Stearate,

PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin.

Principal Display Panel

Keep Oot of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

Temporarily shrinks hemorrhoidal tissue and relieves pain, soreness,

burning, itching, and discomfort associated with hemorrhoids.

Purpose

Local anesthetic,Vasoconstrictor

Stop Use

• bleeding occurs • condition worsens or does not improve within 7 days

• redness, irritation, swelling, pain, or rash develops

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

Warnings

For external use only Allergy alert: do not use if you have a history of allergy to amide-type

local anesthetics (e.g., lidocaine).

Ask Doctor

• heart disease, high blood pressure, thyroid disease, or diabetes •

difficulty urinating due to an enlarged prostate • allergies to amide-type

local anesthetics

Directions

Adults: When practical, cleanse the affected area with mild soap and

warm water, rinse thoroughly, and gently dry. Apply to the affected area

up to 4 times daily, especially at night, in the morning, and after each

bowel movement. To use applicator: lubricate applicator; gently insert

partway into the anal canal and apply a small amount. Clean applicator

after each use.

Children under 12 years of age: ask a doctor.

Do Not Use (Do not use)

• if the tube seal is broken or missing • in children under 12 years of age

unless directed by a doctor • for more than 7 days unless directed by a

doctor

When Using

• avoid contact with eyes • do not exceed the recommended dosage

unless directed by a doctor • do not put this product into the rectum (use

the applicator as directed) • if introduction of applicator causes additional

pain, stop use and ask a docto

Active Ingredient

Lidocaine 5% Phenylephrine HCl 0.25%

Other Information (Other information)

Store at 20–25°C (68–77°F).

Inactive Ingredients (Inactive ingredients)

Purified Water,Witch Hazel Extract, Aloe Vera Extract, Boswellia serrata Extract, Sophora,

japonica Extract, Calendula Extract, Centella asiatica Extract, Vitamin E

(Tocopherol), Tocopheryl Acetate, Petrolatum USP, Shea Butter, Glycerin,

Caprylic/Capric Triglycerides (MCT), Cetearyl Alcohol, Glyceryl Stearate,

PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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