SPL v1
SPL
SPL Set ID 984c4bee-0d44-4e0f-a057-0d54400c4cac
Route
TOPICAL
Published
Effective Date 2025-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (5 g)
Inactive Ingredients
Allantoin Aloe Vera Leaf Juice Benzyl Alcohol Carbomer Cholesterol Dimethyl Isosorbide Edetate Disodium Hydrogenated Polydecene Type I Hydrogenated Soybean Lecithin Neopentyl Glycol Dicaprylate/dicaprate Propylene Glycol Sodium Polyacrylate (2500000 Mw) .alpha.-tocopherol Acetate, D- Trideceth-6 Trolamine Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-07

Description

Lidocaine 5%                                 Local Anesthetic

Purpose

Lidocaine 5%                                 Local Anesthetic


Medication Information

Purpose

Lidocaine 5%                                 Local Anesthetic

Description

Lidocaine 5%                                 Local Anesthetic

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.
Section 50565-1

Section 55105-1

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.
  • 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.
Drug Facts

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 6 times daily.
Product Label

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.
Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine, Water

Active Ingredients                        Purpose

Lidocaine 5%                                 Local Anesthetic


Structured Label Content

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.
Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

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.
  • 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.
Drug Facts (DRUG FACTS)

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 6 times daily.
Product Label (Product label)

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.
Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine, Water

Active Ingredients                        Purpose

Lidocaine 5%                                 Local Anesthetic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)