SPL v1
SPL
SPL Set ID 606958bb-33e8-6a69-e053-2991aa0ab0e4
Route
TOPICAL
Published
Effective Date 2017-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (3.4 g)
Inactive Ingredients
Propylene Glycol Isopentyldiol Carboxymethylcellulose Calcium Diazolidinyl Urea Methylparaben Water Propylparaben Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-12-15
Description

Lidocaine 5%

Medication Information

Warnings and Precautions
  • For external use only. Do not use this product with a mechanical device.
  • 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 exceed the daily recommended dosage
  • In case of any bleeding, discontinue use and consult a doctor.
  • Avoid contact with eyes, in case of eye contact, flush with water.
Indications and Usage

For temporary relief of pain, soreness, or burning in the perianal area.

Dosage and Administration
  • Cleanse affected area with mild soap and water.
  • Gently dry by patting or blotting with soft cloth or tissue before application.
  • Apply externally to the affected area up to 6 times daily.
Description

Lidocaine 5%

Section 50565-1
  • Keep this and all drugs out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
  • As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
Section 51727-6

Cellulose Gum, Diazolidinyl Urea, Glycerin, Isopentyldiol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water (Aqua).

Section 51945-4

Section 55105-1

Anorectal

Section 55106-9

Lidocaine 5%

Section 60561-8
  • Store at room temperature 20-25°C (68-77°F).
  • Tamper-Evident: Do not use if tamper evident seal under cap is broken or missing.

Structured Label Content

Indications and Usage (34067-9)

For temporary relief of pain, soreness, or burning in the perianal area.

Dosage and Administration (34068-7)
  • Cleanse affected area with mild soap and water.
  • Gently dry by patting or blotting with soft cloth or tissue before application.
  • Apply externally to the affected area up to 6 times daily.
Warnings and Precautions (34071-1)
  • For external use only. Do not use this product with a mechanical device.
  • 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 exceed the daily recommended dosage
  • In case of any bleeding, discontinue use and consult a doctor.
  • Avoid contact with eyes, in case of eye contact, flush with water.
Section 50565-1 (50565-1)
  • Keep this and all drugs out of reach of children. If swallowed, seek medical help or call a Poison Control Center right away.
  • As with any drug, consult a health care professional if you are pregnant or nursing. Ask a health care professional before using this product.
Section 51727-6 (51727-6)

Cellulose Gum, Diazolidinyl Urea, Glycerin, Isopentyldiol, Methylparaben, Propylene Glycol, Propylparaben, Purified Water (Aqua).

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Anorectal

Section 55106-9 (55106-9)

Lidocaine 5%

Section 60561-8 (60561-8)
  • Store at room temperature 20-25°C (68-77°F).
  • Tamper-Evident: Do not use if tamper evident seal under cap is broken or missing.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:27.883722 · Updated: 2026-03-14T22:54:57.020531