36caf20d-116a-f86a-e063-6294a90a7b62

SPL v1
SPL
SPL Set ID 36caf20d-116a-f86a-e063-6294a90a7b62
Route
topical
Published
Effective Date 2019-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (4 mg) phenylephrine (2.5 mg)
Inactive Ingredients
ethylhexylglycerin glycerin petrolatum lecithin, soybean mineral oil aloe barbadensis leaf juice ascorbic acid hydrocortisone water zea mays (corn) oil isopropyl myristate mentha piperita (peppermint) oil panax ginseng root silica cholecalciferol, (5e)- dimethyl isosorbide dodecane ethoxydiglycol hexylene glycol peg-8 dimethicone phenoxyethanol egg phospholipids polyethylene propylene glycol retinyl palmitate triethoxycaprylylsilane zinc oxide isododecane ascorbyl palmitate microcrystalline wax octyldodecanol pomegranate pyridoxine hcl sodium propoxyhydroxypropyl thiosulfate silica stearic acid .alpha.-tocopherol acetate, d- caprylyl glycol chamomile carthamus tinctorius (safflower) seed oil cetearyl alcohol cholesterol diisopropyl sebacate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2019-11-01

Description

Active Ingredients Lidocaine 4.00% 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.

Active Ingredient

Active Ingredients

Lidocaine 4.00%

Phenylephrine HCl 0.25%

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 4.00% Phenylephrine HCl 0.25%

Section 50565-1

■ 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.

Section 51727-6

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Cholesterol, Diisopropyl Sebacate, Dimethyl Isosorbide, Dodecane, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrocortisone, Isododecane, Isopropyl Myristate, Lecithin, Mentha Piperita (Peppermint) Oil, Microcrystalline Wax, Mineral Oil, Octyldodecanol, Panax Ginseng Root Extract, PEG-8 Dimethicone, Petrolatum, Phenoxyethanol, Phospholipids, Polyethylene, Propylene Glycol, Punica Granatum Extract, Pyridoxine HCl, Retinyl Palmitate, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water, Zea Mays (Corn) Oil, Zinc Oxide

Section 51945-4

Section 55105-1

Purpose

Local Anesthetic

Vasoconstrictor

Section 60561-8

Other Information

■ Keep away from direct sunlight or heat.

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

■ 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.


Structured Label Content

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.

Active Ingredient (55106-9)

Active Ingredients

Lidocaine 4.00%

Phenylephrine HCl 0.25%

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.

Section 50565-1 (50565-1)

■ 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.

Section 51727-6 (51727-6)

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Ascorbic Acid, Ascorbyl Palmitate, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Cholecalciferol, Cholesterol, Diisopropyl Sebacate, Dimethyl Isosorbide, Dodecane, Ethoxydiglycol, Ethylhexylglycerin, Glycerin, Hexylene Glycol, Hydrocortisone, Isododecane, Isopropyl Myristate, Lecithin, Mentha Piperita (Peppermint) Oil, Microcrystalline Wax, Mineral Oil, Octyldodecanol, Panax Ginseng Root Extract, PEG-8 Dimethicone, Petrolatum, Phenoxyethanol, Phospholipids, Polyethylene, Propylene Glycol, Punica Granatum Extract, Pyridoxine HCl, Retinyl Palmitate, Silica, Sodium Propoxyhydroxypropyl Thiosulfate Silica, Stearic Acid, Tocopheryl Acetate, Triethoxycaprylylsilane, Water, Zea Mays (Corn) Oil, Zinc Oxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Local Anesthetic

Vasoconstrictor

Section 60561-8 (60561-8)

Other Information

■ Keep away from direct sunlight or heat.

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

■ 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.


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