SPL v2
SPL
SPL Set ID 350f0e25-fbdc-c0c0-e063-6294a90a50a0
Route
TOPICAL
Published
Effective Date 2025-05-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Arginine Sodium Benzoate Ethoxydiglycol Edetate Disodium Anhydrous Anhydrous Citric Acid Benzyl Alcohol Diethylene Glycol Monoethyl Ether Acetate Hamamelis Virginiana (witch Hazel) Leaf Water Polysorbate 20 Water Sodium Sulfite Aloe Barbadensis Leaf Juice Matricaria Chamomilla Flowering Top Phenoxyethanol Allantoin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-13

Description

Active Ingredients Purpose Lidocaine 5% ………………………………………….Local Anesthetic Phenylephrine HCl 0.25% ………………………….....Vasoconstrictor


Medication Information

Warnings and Precautions

Warnings

■ 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.

■ Do not put this product into the rectum by using fingers or any mechanical device or applicator.

■ 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.

■ 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.

Indications and Usage

Uses

■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.

■ For the temporary relief of pain, burning and soreness.

■ Temporarily shrinks hemorrhoidal tissue.

■ Temporarily reduces the swelling associated with irritation in hemorrhoids 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.

■ Apply externally to the affected area up to 4 times daily.

Description

Active Ingredients Purpose Lidocaine 5% ………………………………………….Local Anesthetic Phenylephrine HCl 0.25% ………………………….....Vasoconstrictor

Section 50565-1

Other Information

■ Keep away from direct sunlight or heat.

■ Store at room temperature 15°-30°C (59°-86°F).

■ This package is child-resistant. Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

Section 51727-6

Inactive Ingredients

Alcohol, Allantoin, Aloe Barbadensis Leaf Juice, Arginine Hydrochloride, Benzyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Disodium EDTA, Ethoxydiglycol, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate 20, Propylene Glycol, Sodium Benzoate, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Sodium Metabisulfite, Sodium Sulfite, Water

Section 51945-4

NUMB520

SPRAY

5% Lidocaine

0.25% Phenylephrine HCl

CHILD-RESISTANT PACKAGING

Topical Anorectal Spray

2.4 fl.oz e 72 mL

Section 55105-1

Purpose………………………………………….Local Anesthetic

Section 55106-9

Active Ingredients Purpose

Lidocaine 5% ………………………………………….Local Anesthetic

Phenylephrine HCl 0.25% ………………………….....Vasoconstrictor


Structured Label Content

Indications and Usage (34067-9)

Uses

■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.

■ For the temporary relief of pain, burning and soreness.

■ Temporarily shrinks hemorrhoidal tissue.

■ Temporarily reduces the swelling associated with irritation in hemorrhoids 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.

■ Apply externally to the affected area up to 4 times daily.

Warnings and Precautions (34071-1)

Warnings

■ 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.

■ Do not put this product into the rectum by using fingers or any mechanical device or applicator.

■ 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.

■ 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.

Section 50565-1 (50565-1)

Other Information

■ Keep away from direct sunlight or heat.

■ Store at room temperature 15°-30°C (59°-86°F).

■ This package is child-resistant. Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

Section 51727-6 (51727-6)

Inactive Ingredients

Alcohol, Allantoin, Aloe Barbadensis Leaf Juice, Arginine Hydrochloride, Benzyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Disodium EDTA, Ethoxydiglycol, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate 20, Propylene Glycol, Sodium Benzoate, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Sodium Metabisulfite, Sodium Sulfite, Water

Section 51945-4 (51945-4)

NUMB520

SPRAY

5% Lidocaine

0.25% Phenylephrine HCl

CHILD-RESISTANT PACKAGING

Topical Anorectal Spray

2.4 fl.oz e 72 mL

Section 55105-1 (55105-1)

Purpose………………………………………….Local Anesthetic

Section 55106-9 (55106-9)

Active Ingredients Purpose

Lidocaine 5% ………………………………………….Local Anesthetic

Phenylephrine HCl 0.25% ………………………….....Vasoconstrictor


Advanced Ingredient Data


Raw Label Data

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