NUMB25- lidocaine 5% cream

Numb25 by

Drug Labeling and Warnings

Numb25 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 Ingredient Purpose

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

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.

WARNINGS

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.

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 6 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

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

PURPOSE

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

PRINCIPAL DISPLAY PANEL

NUMB25

5% LIDOCAINE

CHILD-RESISTANT PACKAGING

Topical Anorectal Cream

1.35 oz e 38g

INGREDIENTS AND APPEARANCE

NUMB25 
lidocaine 5% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72654-035
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 g

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ALOE BARBADENSIS LEAF JUICE (UNII: RUE8E6T4NB)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HYDROGENATED POLYDECENE (1500 CST) (UNII: 4YI0729529)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
WATER (UNII: 059QF0KO0R)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
CARBOMER (UNII: 0A5MM307FC)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TOCOPHEROL (UNII: R0ZB2556P8)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
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: 72654-035-01	38 g in 1 BOTTLE, PLASTIC; 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(72654-035)