NUMB 100- lidocaine cream 
Clinical Resolution Laboratory, Inc.

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Numb 100

DRUG FACTS

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses:

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

Warnings

(For external use only)

Do not use

this product if

Pregnant or breast-feeding,

  • ask a health professional before use.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately.
  • Tamper Evident "Warranty Void...Seal..."label atop the container is broken.

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 fingers 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

Other Information

Inactive Ingredients

Water, Triethanolamine, Carbomer, Propylene Glycol, Benzyl Alcohol, Ethoxydiglycol, Lecithin, Neopentyl Glycol Dicaprylate/Dicaprate, Sodium Polacrylate, Hydrogenated Polycene, Trideceth-10, Cholesterol, Allantoin, Tocopheryl Acetate, Polysorbate-80

Package Labeling:

Label

NUMB 100 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
TRIDECETH-10 (UNII: G624N6MSBA)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ALLANTOIN (UNII: 344S277G0Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63742-003-0138 g in 1 BOTTLE; Type 0: Not a Combination Product06/18/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01506/18/2016
Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Revised: 12/2023
Document Id: 0d762cea-b5e2-6ff1-e063-6394a90aee03
Set id: e75eb3e0-853b-4b85-8c31-86cbf58effaa
Version: 4
Effective Time: 20231226
 
Clinical Resolution Laboratory, Inc.