initial drug listing - 5% lidocaine numbing cream

initial drug listing - 5% lidocaine numbing cream
SPL v1
SPL
SPL Set ID 35b5ba9d-da1d-55d6-e063-6294a90a5fa8
Route
topical
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (7 mg) lidocaine (50 mg)
Inactive Ingredients
water alpha-tocopherol acetate carbomer 934 benzyl alcohol propylene glycol emu oil arnica montana flower lecithin, soybean

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-12
Description

Lidocaine 5% Menthol 0.7%

Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Lidocaine 5%

Menthol 0.7%

Indications and Usage

For temporary relief local discomfort, itching, pain, soreness, or burning inthe perianal area associated with anorectal disorders and anorectal inflammation.

Dosage and Administration
  • For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
  • Apply up to 4 times a day.
  • For children under 12 years of age: Consult a doctor.
Description

Lidocaine 5% Menthol 0.7%

Section 50565-1

Keep out of reach of children

Avoid contact with eyes.

In case of accidental ingestion, seek medical attention immediately.

Section 50566-9

Stop using and ask a doctor

  • If discomfort persists for 7 days.
  • The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.
Section 50567-7
  • Only take the recommended daily dosage unless otherwise instructed by a doctor.
  • Some individuals may experience allergic reactions to the ingredientscontained in this product.
  • Never put it into the rectum by using the finger or any medical device.
Section 50570-1

Do not use this product if

  • Pregnant or breastfeeding, ask a health professional before use.
  • If there is any allergic reaction to this product.
  • In case of accidental overdose, get medical help, or contact the poison control center immediately.
Section 51727-6

Water, Arnica, Emu Oil, Lecithin(Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer 934, Benzyl Alcohol.

Section 51945-4

Section 55105-1

Local Anesthetic

Local Anesthetic

Section 60561-8
  • Keep away from direct sunlight or heat.
  • Store at room temperature 59~-86°F(15°-30°C).

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Lidocaine 5%

Menthol 0.7%

Indications and Usage (34067-9)

For temporary relief local discomfort, itching, pain, soreness, or burning inthe perianal area associated with anorectal disorders and anorectal inflammation.

Dosage and Administration (34068-7)
  • For adults: Cleanse the affected area with mild soap and warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying the product.
  • Apply up to 4 times a day.
  • For children under 12 years of age: Consult a doctor.
Section 50565-1 (50565-1)

Keep out of reach of children

Avoid contact with eyes.

In case of accidental ingestion, seek medical attention immediately.

Section 50566-9 (50566-9)

Stop using and ask a doctor

  • If discomfort persists for 7 days.
  • The symptoms being treated do not subside or if redness irritation swelling, pain, or other symptoms develop or increase.
Section 50567-7 (50567-7)
  • Only take the recommended daily dosage unless otherwise instructed by a doctor.
  • Some individuals may experience allergic reactions to the ingredientscontained in this product.
  • Never put it into the rectum by using the finger or any medical device.
Section 50570-1 (50570-1)

Do not use this product if

  • Pregnant or breastfeeding, ask a health professional before use.
  • If there is any allergic reaction to this product.
  • In case of accidental overdose, get medical help, or contact the poison control center immediately.
Section 51727-6 (51727-6)

Water, Arnica, Emu Oil, Lecithin(Soybean), Propylene Glycol,Tocopheryl Acetate, Carbomer 934, Benzyl Alcohol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Local Anesthetic

Local Anesthetic

Section 60561-8 (60561-8)
  • Keep away from direct sunlight or heat.
  • Store at room temperature 59~-86°F(15°-30°C).

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.859455 · Updated: 2026-03-14T23:08:59.288880