LIDOCAINE 5% TOPICAL ANORECTAL CREAM- lidocaine 5% topical anorectal cream cream 
Mohnark Pharmaceuticals Inc.

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Active Ingredients

Lidocaine 5% w/w

Purpose

Local Anesthetic

Uses

helps relieves pain, itching and burning associated with hemorrhoids and other anorectal disorders

Warnings

For external use only

When using this product

Stop use and ask doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, water.

Dosage

50 milligrams/gram per application

Usage

Package Label

5% Lidocaine cream

LIDOCAINE 5% TOPICAL ANORECTAL CREAM 
lidocaine 5% topical anorectal cream cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73715-002
Route of AdministrationRECTAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE5.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 80 (UNII: 6OZP39ZG8H) 2 g  in 100 g
WATER (UNII: 059QF0KO0R) 80 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73715-002-0130 g in 1 TUBE; Type 0: Not a Combination Product06/15/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01506/15/2020
Labeler - Mohnark Pharmaceuticals Inc. (117013830)
Establishment
NameAddressID/FEIBusiness Operations
Mohnark Pharmaceuticals Inc.117013830manufacture(73715-002)

Revised: 1/2024
Document Id: 0fa8fbd1-d030-84c7-e063-6394a90a9533
Set id: a7205326-18dc-2ebb-e053-2995a90a8312
Version: 3
Effective Time: 20240123
 
Mohnark Pharmaceuticals Inc.