initial drug listing - 4% numbing cream

initial drug listing - 4% numbing cream
SPL v1
SPL
SPL Set ID 35884644-d017-eda3-e063-6394a90a1f6c
Route
topical
Published
Effective Date 2025-06-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (40 mg)
Inactive Ingredients
propylene glycol benzyl alcohol water arnica montana flower emu oil lecithin, soybean carbomer 934 alpha-tocopherol acetate

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-06-09
Description

4% lidocaine

Medication Information

Warnings and Precautions

For external use only

Active Ingredient

4% lidocaine

Indications and Usage

For the temporary relief of pain and itching, associated with minor skin irritations, minor burns, sunburn, 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

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

Section 51945-4

Section 55105-1

topical analgesic

Section 60561-8

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

Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

4% lidocaine

Indications and Usage (34067-9)

For the temporary relief of pain and itching, associated with minor skin irritations, minor burns, sunburn, 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.
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)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

topical analgesic

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: 2026-02-15T12:06:15.555005 · Updated: 2026-03-14T23:08:56.104871