NUMB520SPRAY- lidocaine, phenylephrine hcl liquid

Numb520Spray by

Drug Labeling and Warnings

Numb520Spray by is a Otc medication manufactured, distributed, or labeled by Ebanel Laboratories, Inc., Clinical Resolution Laboratory, Inc., Clinical Resolution Laboratory, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

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

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

INDICATIONS & USAGE

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.

WARNINGS

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

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.

KEEP OUT OF REACH OF CHILDREN

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

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

PURPOSE

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

PRINCIPAL DISPLAY PANEL

NUMB520

SPRAY

5% Lidocaine

0.25% Phenylephrine HCl

CHILD-RESISTANT PACKAGING

Topical Anorectal Spray

2.4 fl.oz e 72 mL

INGREDIENTS AND APPEARANCE

NUMB520SPRAY 
lidocaine, phenylephrine hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72654-037
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARGININE (UNII: 94ZLA3W45F)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DIETHYLENE GLYCOL MONOETHYL ETHER ACETATE (UNII: W5EIM81UBX)
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER (UNII: 8FP93ED6H2)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
SODIUM SULFITE (UNII: VTK01UQK3G)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALLANTOIN (UNII: 344S277G0Z)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72654-037-02	72 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	05/13/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	05/13/2025

Labeler - Ebanel Laboratories, Inc. (079352161)

Registrant - Clinical Resolution Laboratory, Inc. (825047942)

Establishment
Name	Address	ID/FEI	Business Operations
Clinical Resolution Laboratory, Inc		825047942	manufacture(72654-037)