Initial Drug Listing - 4% Lidocaine Numbing Cream

Initial Drug Listing - 4% Lidocaine Numbing Cream
SPL v1
SPL
SPL Set ID 359884d6-188a-e503-e063-6294a90acab4
Route
TOPICAL
Published
Effective Date 2025-06-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg)
Inactive Ingredients
Water .alpha.-tocopherol Acetate Emu Oil Propylene Glycol Arnica Montana Flower Lecithin, Soybean Benzyl Alcohol Carbomer 934

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-11
Description

4% lidocaine

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the temporary relief of pain and itching!associated with minor skin irritations, minor burnssunburn,minor cuts,scrapes, insect bites.

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

4% lidocaine

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 ingredients contained in this product.
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

topical analgesic

Section 55106-9

4% lidocaine

Section 60561-8

Store at 59°-86°F (15°-30°C). Avoid direct sunlight.

Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain and itching!associated with minor skin irritations, minor burnssunburn,minor cuts,scrapes, insect bites.

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.
Warnings and Precautions (34071-1)

For external use only

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 ingredients contained in this product.
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)

topical analgesic

Section 55106-9 (55106-9)

4% lidocaine

Section 60561-8 (60561-8)

Store at 59°-86°F (15°-30°C). Avoid direct sunlight.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:17.000849 · Updated: 2026-03-14T23:08:57.795400