SPL v1
SPL
SPL Set ID 36eccc74-107e-3914-e063-6294a90a1856
Route
TOPICAL
Published
Effective Date 2025-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Disodium Edta-copper Alcohol Carbomer Xanthan Gum Chamomile Witch Hazel Sodium Citrate Stearic Acid Triethanolamine .alpha.-tocopherol Acetate, D- Indian Frankincense Hexylene Glycol Peg-100 Stearate Lavandula Angustifolia (lavender) Oil Citric Acid Pomegranate Caprylyl Glycol Bht Centella Asiatica Leaf Dimethicone Argania Spinosa Kernel Oil Cetearyl Alcohol Aloe Barbadensis Leaf Juice Cetearyl Glucoside Sodium Metabisulfite Bha Ethylhexylglycerin Panax Ginseng Root Pyridoxine Hcl Horse Chestnut Zinc Oxide Glyceryl Stearate Se Panthenol Water Isopropyl Myristate Carthamus Tinctorius (safflower) Seed Oil Calendula Officinalis Flower Camellia Sinensis Var. Assamica Whole Cocos Nucifera (coconut) Oil Hydroxyethylcellulose Petrolatum Phenoxyethanol Glycerin Myrtus Communis Oil

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-06

Description

Active Ingredients Lidocaine 5.00% Phenylephrine HCl 0.25%


Medication Information

Warnings and Precautions

Warnings: For external and / or intrarectal use only.

■ 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.

■ 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.

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

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.

■ For External Use: Apply externally to the affected area up to 4 times daily.

■ For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.

Description

Active Ingredients Lidocaine 5.00% Phenylephrine HCl 0.25%

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

Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Alcohol, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, BHA, BHT, Boswellia Serrata Resin Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylyl Glycol, Carbomer, Carthamus Tinctorius (Safflower) Seed Oil, Centella Asiatica Extract, Cetearyl Alcohol, Cetearyl Glucoside, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hexylene Glycol, Hydroxyethylcellulose, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Myrtus Communis Oil, Panax Ginseng Root Extract, Panthenol, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Punica Granatum Fruit Extract, Pyridoxine HCl, Sodium Citrate, Sodium Metabisulfite, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Water, Xanthan Gum, Zinc Oxide

Section 51945-4

Section 55105-1

Purpose

Local Anesthetic

Vasoconstrictor

Section 55106-9

Active Ingredients

Lidocaine 5.00%

Phenylephrine HCl 0.25%


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.

■ For External Use: Apply externally to the affected area up to 4 times daily.

■ For Intrarectal use: Attach applicator to tube. Lubricate applicator well, then gently insert applicator into the rectum. Apply to the affected area up to 4 times daily.

Warnings and Precautions (34071-1)

Warnings: For external and / or intrarectal use only.

■ 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.

■ 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.

■ 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 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

Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Alcohol, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, BHA, BHT, Boswellia Serrata Resin Extract, Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Caprylyl Glycol, Carbomer, Carthamus Tinctorius (Safflower) Seed Oil, Centella Asiatica Extract, Cetearyl Alcohol, Cetearyl Glucoside, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cocos Nucifera (Coconut) Oil, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Hamamelis Virginiana (Witch Hazel) Water, Hexylene Glycol, Hydroxyethylcellulose, Isopropyl Myristate, Lavandula Angustifolia (Lavender) Oil, Myrtus Communis Oil, Panax Ginseng Root Extract, Panthenol, PEG-100 Stearate, Petrolatum, Phenoxyethanol, Punica Granatum Fruit Extract, Pyridoxine HCl, Sodium Citrate, Sodium Metabisulfite, Stearic Acid, Tocopheryl Acetate, Triethanolamine, Water, Xanthan Gum, Zinc Oxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Local Anesthetic

Vasoconstrictor

Section 55106-9 (55106-9)

Active Ingredients

Lidocaine 5.00%

Phenylephrine HCl 0.25%


Advanced Ingredient Data


Raw Label Data

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