5% Lidocaine Cream

5% Lidocaine Cream
SPL v2
SPL
SPL Set ID 1604daec-812f-4684-ba98-fbcda07a7461
Route
TOPICAL
Published
Effective Date 2025-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Water Isopropyl Myristate Polysorbate 80 Propylene Glycol Benzyl Alcohol Carbomer Triethanolamine .alpha.-tocopherol Acetate, Dl- Lecithin, Sunflower Cholesterol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-28

Description

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic

Purpose

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic


Medication Information

Indications and Usage

Uses •For the temporary relief of local itching and discomfort associated with anorectal disorders. • For temporary relief of pain,burning and soreness.

Purpose

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic

Description

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic

Section 51945-4

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.

• Apply to the affected area up to 6 times daily.

Children under 12 years of age: consult a doctor

Inactive Ingredients

Benzyl Alcohol, Carbomer, Cholesterol, DL ALPHA Tocopheryl Acetate.Hydrogenated Lecithin, lsopropyl Myristate, Polysorbate80, Propylene Glycol, Triethanolamine, Water

Keep Out of Reach of Children

. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

(1-800-222-1222)

Warnings (for External 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.

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

Stop and ask a doctor if -an allergic reaction occurs - symptom does not improve or if redness, irritation, swelling, pain or other symptom develop or increase.

Active Ingredient                             purpose

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic


Structured Label Content

Indications and Usage (34067-9)

Uses •For the temporary relief of local itching and discomfort associated with anorectal disorders. • For temporary relief of pain,burning and soreness.

Section 51945-4 (51945-4)

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.

• Apply to the affected area up to 6 times daily.

Children under 12 years of age: consult a doctor

Inactive Ingredients (Inactive ingredients)

Benzyl Alcohol, Carbomer, Cholesterol, DL ALPHA Tocopheryl Acetate.Hydrogenated Lecithin, lsopropyl Myristate, Polysorbate80, Propylene Glycol, Triethanolamine, Water

Keep Out of Reach of Children (Keep out of reach of children)

. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.

(1-800-222-1222)

Warnings (for External Use Only) (Warnings (For external 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.

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

Stop and ask a doctor if -an allergic reaction occurs - symptom does not improve or if redness, irritation, swelling, pain or other symptom develop or increase.

Active Ingredient                             purpose (Active Ingredient                             Purpose)

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic


Advanced Ingredient Data


Raw Label Data

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