NUMB520- lidocaine hydrochloride cream

Numb520 by

Drug Labeling and Warnings

Numb520 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 Ingredient

Lidocaine HCl 5%

Purpose

Local Anesthetic

Uses:

for the temporary relief of local and anorectal discomfort associated with anorectal disorders or inflammation.

Warnings

(For external use only)

Do not use this product if

• pregnant or breastfeeding, ask a health professional before use.
• in case of accidental overdose, get medical help or contact the Poison Control Center immediately.
• tamper evident "Do not use this product" if seal is broken or missing.

When using this product

• do not exceed the recommended daily dosage unless directed by a doctor.
• certain persons can develop allergic reactions to ingredients in this product.
• do not put this product into the rectum by using finger or any medical device or applicator.

Stop use and ask a doctor if

the symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase

Keep out of reach of children

In case of accidental ingestion, seek medical attention immediately.

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.
• Apply up to 6 times a day.
• Children under 12 years of age: consult a doctor.

Other Information

• keep away from direct sunlight or heat.
• store in room temperature (59-86°F/15-30°C)

Inactive Ingredients

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

Package Labeling:

Package Labeling: (

63742-030-01)

INGREDIENTS AND APPEARANCE

NUMB520 
lidocaine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-030-00	125 g in 1 BOTTLE; Type 0: Not a Combination Product	09/12/2019
2	NDC: 63742-030-01	39 g in 1 JAR; Type 0: Not a Combination Product	03/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part346	09/12/2019

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Establishment
Name	Address	ID/FEI	Business Operations
Clinical Resolution Laboratory, Inc.		825047942	manufacture(63742-030) , label(63742-030) , pack(63742-030)