85248-031

85248-031
SPL v1
SPL
SPL Set ID 4996f96a-898e-de01-e063-6394a90a3907
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
Aloe Borneol Glycerin Chlorhexidine Acetate Carbomer Homopolymer, Unspecified Type Thymol

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 shrink hemorrhoidal tissue, relieving pain,soreness, burning, itching, anddiscomfort 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 external use only, including the skin around 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

Children under 12 years of age consult your pediatrician. 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 put this product into the rectum.

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.

Active Ingredient

Lidocaine 4% Phenylephrine HCl 0.25%

Other Information

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

Inactive Ingredients

Borneol,Carbomer Homopolymer,Chlorhexidine Acetate ,Glycerin, Thymol, Aloe

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 shrink hemorrhoidal tissue, relieving pain,soreness, burning, itching, anddiscomfort 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 external use only, including the skin around 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

Children under 12 years of age consult your pediatrician. 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)

Do not put this product into the rectum.

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.

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)

Borneol,Carbomer Homopolymer,Chlorhexidine Acetate ,Glycerin, Thymol, Aloe

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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