BASE NUMB TOPICAL ANORECTAL- lidocaine, menthol spray 
Joonem LLC

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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Base Numb Topical Anorectal Spray

Drug Facts

Active ingredients

Lidocaine 4%

Menthol 1%

Purpose

Topical Analgesic

Indications:

Temporary relieves minor pain

Warnings:

Avoid contact with the eyes. If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly. 
  • Do not use in large quantities, particularly over raw surfaces or blistered areas.

Keep out of reach of children to avoid accidental ingestion!

If swallowed, get medical help or contact a poison control center immediately.

Directions:

  • use only as directed
  • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • Children under 12 years of age: consult a doctor

Other Information:

Store at 20 to  25 C (68 to 77 F)

Inactive Ingredients:

L-arginine, Sodium Benzoate, Rectified Spirit, Disodium EDTA, Phenoxyethanol, Polysorbate 20, DM Water

Package Labeling:

Label2

BASE NUMB TOPICAL ANORECTAL 
lidocaine, menthol spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80327-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ARGININE (UNII: 94ZLA3W45F)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80327-001-01120 mL in 1 BOTTLE; Type 0: Not a Combination Product09/01/202009/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/01/202009/01/2020
Labeler - Joonem LLC (117633878)

Revised: 9/2020
Document Id: af824e1f-7c84-f4ea-e053-2a95a90a0f21
Set id: aee48144-c5b0-23fa-e053-2995a90af9d0
Version: 2
Effective Time: 20200917
 
Joonem LLC