Initial Drug Listing - Treatonic 5% Lidocaine Cream

Initial Drug Listing - Treatonic 5% Lidocaine Cream
SPL v1
SPL
SPL Set ID 47dc7630-9a74-1989-e063-6294a90a50bb
Route
TOPICAL
Published
Effective Date 2026-01-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (3 g) Menthol (0.42 g)
Inactive Ingredients
Lecithin, Soybean Emu Oil Carbomer 934 Water Arnica Montana Alpha-tocopherol Acetate Benzyl Alcohol Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-22
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 warm water, and rinse thoroughly. Gently dry the area with toilet tissue or a soft cloth before applying theproduct. Apply up to 6 times a day.
  • For children under 12 years of age: Consulta doctor.
Dosage and Administration

For temporary relief local discomfort,itching,pain,soreness, or burning in the perianal area associated with anorectal isorders 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 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 produet.

Never put it into the rectum by using the finger or any medical device.

Section 50568-5
  • lf 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 50570-1
  • 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),Propyiene 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.

Structured Label Content

Indications and Usage (34067-9)
  • 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 theproduct. Apply up to 6 times a day.
  • For children under 12 years of age: Consulta doctor.
Dosage and Administration (34068-7)

For temporary relief local discomfort,itching,pain,soreness, or burning in the perianal area associated with anorectal isorders 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 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 produet.

Never put it into the rectum by using the finger or any medical device.

Section 50568-5 (50568-5)
  • lf 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 50570-1 (50570-1)
  • 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),Propyiene 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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:19.442536 · Updated: 2026-03-14T23:12:31.383435