NUMB 520- lidocaine cream

Numb 520 by

Drug Labeling and Warnings

Numb 520 by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS

Active Ingredients                        Purpose

Lidocaine 5%                                 Local Anesthetic

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

• 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.

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.

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 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

Product label

INGREDIENTS AND APPEARANCE

NUMB 520 
lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-027
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER (UNII: 0A5MM307FC)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-027-01	1 in 1 CARTON	04/07/2025
1		138.9 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M015	04/07/2025

Labeler - Clinical Resolution Laboratory, Inc. (825047942)