MedPath

Numb 520

Approved
Approval ID

350e4d5e-dac7-ae4e-e063-6394a90a76b4

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 27, 2025

Manufacturers
FDA

Ebanel Laboratories, Inc

DUNS: 079352161

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 Code72654-033
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (17)

EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 g
Code: 98PI200987
Classification: ACTIB
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPEInactive
Code: 0A5MM307FC
Classification: IACT
CHOLESTEROLInactive
Code: 97C5T2UQ7J
Classification: IACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEInactive
Code: VLW429K27K
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
DIMETHYL ISOSORBIDEInactive
Code: SA6A6V432S
Classification: IACT
SODIUM POLYACRYLATE (8000 MW)Inactive
Code: 285CYO341L
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT
TRIETHANOLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TRIDECETH-6Inactive
Code: 3T5PCR2H0C
Classification: IACT
HYDROGENATED POLYDECENE (1500 CST)Inactive
Code: 4YI0729529
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 5/13/2025

N520NUMB520

5% LIDOCAINE

CHILD-RESISTANT PACKAGING

Topical Anorectal Cream

4.4 oz e 125 g

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 5/13/2025

Uses

■ For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders and anorectal inflammation.

■ For the temporary relief of pain, burning and soreness.

WARNINGS SECTION

LOINC: 34071-1Updated: 5/13/2025

Warnings (For external use only)

■ If condition worsens or does not improve within 7 days, consult a doctor.

■ Do not exceed the recommended daily dosage unless directed by a doctor.

■ In case of bleeding, consult a doctor promptly.

■ Do not put this product into the rectum by using fingers or any mechanical device or applicator.

■ Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 5/13/2025

Active Ingredient Purpose

Lidocaine 5% ………………………………………….Local Anesthetic

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 5/13/2025

Directions

■ Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.

■ Apply externally to the affected area up to 6 times daily.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 5/13/2025

Other Information

■ Keep away from direct sunlight or heat.

■ Store at room temperature 15°-30°C (59°-86°F).

■ This package is child-resistant. Keep out of reach of children.

■ In case of accidental overdose or ingestion, call a doctor or poison control center immediately.

■ Do not use this product if seal is broken or missing.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 5/13/2025

Inactive Ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Carbomer, Cholesterol, Dimethyl Isosorbide, Disodium EDTA, Hydrogenated Polydecene, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Propylene Glycol, Sodium Polyacrylate, Tocopheryl Acetate, Trideceth-6, Triethanolamine, Water

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 5/14/2025

Purpose………………………………………….Local Anesthetic

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Numb 520 - FDA Drug Approval Details