NUMB520- lidocaine liquid 
Clinical Resolution Laboratory, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Numb520 Spray

DRUG FACTS

Active Ingredient

Lidocaine 5%

Purpose

Local Anesthetic

Uses:

Temporarily relieves pain, itching, or swelling associated with anorectal disorders.

Warnings

(For external use only)

Do not use this product if

  • Pregnant or breastfeeding, ask a health professional before use
  • Tamper-evident shrink band around the container is broken.

When using this product

  • Do not exceed the recommended daily 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.
  • In case of accidental overdose, contact a doctor or Poison Control Center immediately. 

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

  • Sensitivity test advised prior to use. Apply sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs (90 seconds). You may reapply to continue numbing effect.
  • Apply up to 6 times a day.
  • Children under 12 year 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

Water, Aloe Barbadensis (Aloe Vera) Leaf Juice, Propylene Glycol, Benzyl Alcohol, Epinephrine HCL, Citric Acid, Disodium EDTA, Cholesterol, Sodium Metabisulfite, Lecithin, Polysorbate 80, Phenoxyethanol

Package Labeling:

LabelLabel2

NUMB520 
lidocaine liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63742-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CHOLESTEROL (UNII: 97C5T2UQ7J)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EPINEPHRINE HYDROCHLORIDE (UNII: WBB047OO38)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63742-006-00123 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2018
2NDC:63742-006-01251 mL in 1 BOTTLE; Type 0: Not a Combination Product05/15/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34605/15/2018
Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Revised: 12/2022
Document Id: f0d5687d-1bf0-2a41-e053-2a95a90a50c2
Set id: 26d74a03-98c6-4e99-a657-bfdd1b3dbf38
Version: 4
Effective Time: 20221227
 
Clinical Resolution Laboratory, Inc.