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Numbing Cream

Initial Drug Listing - 4% lidocaine numbing cream

Approved
Approval ID

359884d6-188a-e503-e063-6294a90acab4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 20, 2025

Manufacturers
FDA

100 KARMA INC

DUNS: 120186232

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LIDOCAINE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code85569-002
Application NumberM017
Product Classification
M
Marketing Category
C200263
G
Generic Name
LIDOCAINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 20, 2025
FDA Product Classification

INGREDIENTS (9)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
LIDOCAINEActive
Quantity: 4 mg in 100 mL
Code: 98PI200987
Classification: ACTIB
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
EMU OILInactive
Code: 344821WD61
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ARNICA MONTANA FLOWERInactive
Code: OZ0E5Y15PZ
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/11/2025

Numbing Cream

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/11/2025

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/11/2025

4% lidocaine

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/11/2025

topical analgesic

WARNINGS SECTION

LOINC: 34071-1Updated: 6/11/2025

For external use only

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.

  • 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.

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.

Keep out of reach of children Avoid contact with eyes.
In case of accidental ingestion, seek medical attention immediately.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/11/2025
  • 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.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 6/11/2025

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/11/2025

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

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Numbing Cream - FDA Drug Approval Details