Base Numb Topical Anorectal Spray

Base Numb Topical Anorectal by

Drug Labeling and Warnings

Base Numb Topical Anorectal by is a Otc medication manufactured, distributed, or labeled by Joonem LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

BASE NUMB TOPICAL ANORECTAL 
lidocaine, menthol spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80327-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg  in 1 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ARGININE (UNII: 94ZLA3W45F)	Â
SODIUM BENZOATE (UNII: OJ245FE5EU)	Â
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)	Â
PHENOXYETHANOL (UNII: HIE492ZZ3T)	Â
POLYSORBATE 20 (UNII: 7T1F30V5YH)	Â
WATER (UNII: 059QF0KO0R)	Â

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80327-001-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2020	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/01/2020	09/01/2020

Labeler - Joonem LLC (117633878)

Revised: 9/2020

Document Id: af824e1f-7c84-f4ea-e053-2a95a90a0f21

34390-5

Set id: aee48144-c5b0-23fa-e053-2995a90af9d0

Version: 2

Effective Time: 20200917

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