MedPath

Numb520Spray

Approved
Approval ID

350f0e25-fbdc-c0c0-e063-6294a90a50a0

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, Phenylephrine HCl

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72654-037
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Lidocaine, Phenylephrine HCl
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 27, 2025
FDA Product Classification

INGREDIENTS (17)

ARGININEInactive
Code: 94ZLA3W45F
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
ETHOXYDIGLYCOLInactive
Code: A1A1I8X02B
Classification: IACT
EDETATE DISODIUM ANHYDROUSInactive
Code: 8NLQ36F6MM
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
DIETHYLENE GLYCOL MONOETHYL ETHER ACETATEInactive
Code: W5EIM81UBX
Classification: IACT
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATERInactive
Code: 8FP93ED6H2
Classification: IACT
LIDOCAINEActive
Quantity: 50 mg in 1 mL
Code: 98PI200987
Classification: ACTIB
POLYSORBATE 20Inactive
Code: 7T1F30V5YH
Classification: IACT
PHENYLEPHRINE HYDROCHLORIDEActive
Quantity: 2.5 mg in 1 mL
Code: 04JA59TNSJ
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM SULFITEInactive
Code: VTK01UQK3G
Classification: IACT
ALOE BARBADENSIS LEAF JUICEInactive
Code: RUE8E6T4NB
Classification: IACT
MATRICARIA CHAMOMILLA FLOWERING TOPInactive
Code: 3VNC7T6Z02
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
ALLANTOINInactive
Code: 344S277G0Z
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

Numb 520 SprayNUMB520

SPRAY

5% Lidocaine

0.25% Phenylephrine HCl

CHILD-RESISTANT PACKAGING

Topical Anorectal Spray

2.4 fl.oz e 72 mL

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.

■ Temporarily shrinks hemorrhoidal tissue.

■ Temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders.

OTC - ACTIVE INGREDIENT SECTION

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

Active Ingredients Purpose

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

Phenylephrine HCl 0.25% ………………………….....Vasoconstrictor

WARNINGS SECTION

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

Warnings

■ 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.

■ Do not use this product if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

■ Ask a doctor or pharmacist before use if you are presently taking a prescription drug for high blood pressure or depression.

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 4 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

Alcohol, Allantoin, Aloe Barbadensis Leaf Juice, Arginine Hydrochloride, Benzyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Disodium EDTA, Ethoxydiglycol, Glycerin, Hamamelis Virginiana (Witch Hazel) Water, Polysorbate 20, Propylene Glycol, Sodium Benzoate, Sodium Chloride, Sodium Citrate, Sodium Hydroxide, Sodium Metabisulfite, Sodium Sulfite, Water

OTC - PURPOSE SECTION

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

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

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Numb520Spray - FDA Drug Approval Details