Initial Drug Listing - Treatonic Lidocaine Numbing Cream

Initial Drug Listing - Treatonic Lidocaine Numbing Cream
SPL v1
SPL
SPL Set ID 47380721-6633-4a50-e063-6394a90aca94
Route
TOPICAL
Published
Effective Date 2025-12-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.84 g) Lidocaine (6 g)
Inactive Ingredients
Water Emu Oil Lecithin, Soybean Arnica Montana Propylene Glycol Benzyl Alcohol Carbomer 934 .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15
Description

Lidocaine 5% Menthol 0.7%

Medication Information

Warnings and Precautions

For external use only

Indications and Usage
  • For adults: Cleanse the affected area with mild soap and warmwater, and rinse thoroughly, Gently dry the area with toilet tissue or a soft cloth before applying the product,
  • Apply up to 6 times a day,
  • For children under 12 years of age: Consult a doctor.
Dosage and Administration

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

Description

Lidocaine 5% Menthol 0.7%

Section 50565-1

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 ingredients contained 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.
  • lf 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

Section 55106-9

Lidocaine 5%

Menthol 0.7%

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

Structured Label Content

Indications and Usage (34067-9)
  • For adults: Cleanse the affected area with mild soap and warmwater, and rinse thoroughly, Gently dry the area with toilet tissue or a soft cloth before applying the product,
  • Apply up to 6 times a day,
  • For children under 12 years of age: Consult a doctor.
Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

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 ingredients contained 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.
  • lf 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

Section 55106-9 (55106-9)

Lidocaine 5%

Menthol 0.7%

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: 2026-02-15T12:08:08.175572 · Updated: 2026-03-14T23:12:17.704012