85248-027

85248-027
SPL v1
SPL
SPL Set ID 499197aa-f872-3abf-e063-6294a90aeda2
Route
TOPICAL
Published
Effective Date 2026-01-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Phenylephrine (0.25 g)
Inactive Ingredients
Glycerin Aloe Acetyl Dipeptide-1 Cetyl Ester Rhubarb Thymol Oxacycloheptadec-8-en-2-one, (8z)- Panax Notoginseng Root Borneol Carbomer Dipropylenetriamine Chlorhexidine Acetate Polypropylene (67000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-30

Description

Lidocaine 4% Phenylephrine HCl 0.25%

Purpose

Analgesic (pain relief) Vasoconstrictor


Medication Information

Purpose

Analgesic (pain relief) Vasoconstrictor

Description

Lidocaine 4% Phenylephrine HCl 0.25%

Use

Temporarily shrinks hemorrhoidal tissue, for the temporary relief of pain, soreness,or burning, and helps relieve the local it ching and discomfort associated with hemorrhoids.

Stop Use

Ask a doctor before use if you have allergies to any of the components of this product, difficulty in urination due to enlargement of the prostate gland, diabetes, heart disease, high blood pressure, thyroid disease, or presently taking a prescription for high blood pressure or depression.

Warnings

For extemnal use only including the skin of the anal canal.

Ask Doctor

Stop use and ask a doctor if condition worsens or does not improve

within seven days, bleeding occurs, an allergic reaction develops, the

symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

Directions

Adults: apply to affected area up to 3 times daily.Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.

To use dispensing cap, attach it to tube, lubricate well then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

Do Not Use

Children under 12 years of age consult your pediatrician.

When Using

When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only. Do not put this product into the rectum.

Active Ingredient

Lidocaine 4% Phenylephrine HCl 0.25%

Other Information

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

Inactive Ingredients

Aloe,Sangi, Musk, Calmine, Borneol, CarbomerHomopolymer, Chlorhexidine Acetate,Glycerin, Thymol,Rhubarb, Vaseline

Principal Display Panel

Keep Oot of Reach of Children

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


Structured Label Content

Use

Temporarily shrinks hemorrhoidal tissue, for the temporary relief of pain, soreness,or burning, and helps relieve the local it ching and discomfort associated with hemorrhoids.

Purpose

Analgesic (pain relief) Vasoconstrictor

Stop Use

Ask a doctor before use if you have allergies to any of the components of this product, difficulty in urination due to enlargement of the prostate gland, diabetes, heart disease, high blood pressure, thyroid disease, or presently taking a prescription for high blood pressure or depression.

Warnings

For extemnal use only including the skin of the anal canal.

Ask Doctor

Stop use and ask a doctor if condition worsens or does not improve

within seven days, bleeding occurs, an allergic reaction develops, the

symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase.

Directions

Adults: apply to affected area up to 3 times daily.Clean affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.

To use dispensing cap, attach it to tube, lubricate well then gently insert part way into anus and squeeze tube to deliver medication. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly.

Do Not Use (Do not use)

Children under 12 years of age consult your pediatrician.

When Using

When using this product do not exceed recommended daily dosage unless directed by a doctor, when using finger cots or an applicator, apply externally or the skin of the anal canal only. Do not put this product into the rectum.

Active Ingredient

Lidocaine 4% Phenylephrine HCl 0.25%

Other Information (Other information)

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

Inactive Ingredients (Inactive ingredients)

Aloe,Sangi, Musk, Calmine, Borneol, CarbomerHomopolymer, Chlorhexidine Acetate,Glycerin, Thymol,Rhubarb, Vaseline

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

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


Advanced Ingredient Data


Raw Label Data

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