SPL v2
SPL
SPL Set ID f155d10c-158d-4380-a258-e50879254440
Route
TOPICAL
Published
Effective Date 2022-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg)
Inactive Ingredients
Allantoin Aloe Vera Leaf Benzyl Alcohol Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) Cholesterol Dimethyl Isosorbide Edetate Disodium Anhydrous Hydrogenated Polydecene (1500 Cst) Egg Phospholipids Neopentyl Glycol Dicaprylate/dicaprate Propylene Glycol Water Sodium Polyacrylate (8000 Mw) .alpha.-tocopherol Acetate Trideceth-6 Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2021-11-01

Description

Lidocaine 5%

Purpose

Local Anesthetic


Medication Information

Purpose

Local Anesthetic

Description

Lidocaine 5%

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.
Warnings
  • 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.
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

Active Ingredient

Lidocaine 5%

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

Allanloin, Aloe Barbadensis Leaf Juice, Benzyt Alcohol,Carbomer, Cholesterol, Dlmethyt lsosorbide, DisodiumEDTA, Hydrogenated Polydecene, Lecithin, NeopenlytGlycol Dicaprylale/Dicaprate. Propylene Glycol, Water,Sodium Polyacrytate, Tocopheryt Acetate, Trideceth-6,Triethanolamine

Keep Out of Reach of Children

In case of accidental ingestion, seek medical attention immediately.


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.
Purpose

Local Anesthetic

Warnings
  • 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.
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)

Active Ingredient

Lidocaine 5%

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

Allanloin, Aloe Barbadensis Leaf Juice, Benzyt Alcohol,Carbomer, Cholesterol, Dlmethyt lsosorbide, DisodiumEDTA, Hydrogenated Polydecene, Lecithin, NeopenlytGlycol Dicaprylale/Dicaprate. Propylene Glycol, Water,Sodium Polyacrytate, Tocopheryt Acetate, Trideceth-6,Triethanolamine

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

In case of accidental ingestion, seek medical attention immediately.


Advanced Ingredient Data


Raw Label Data

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