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

Purpose

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic

Description

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

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

Description

Lidocaine 5%                                    Local Anorectal(hemorrhoidal) Anesthetic

Section 51945-4

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.

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

Section 51945-4 (51945-4)

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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