LMX5- lidocaine cream 
Ferndale Laboratories, Inc.

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LMX5 (lidocaine 5%) Anorectal Cream

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

temporarily relieves pain and itching due to anorectal disorders

Warnings


When using this product

  • avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor

Stop use and ask a doctor if

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs
  • redness, irritation, swelling, pain or other symptoms begin or increase
  • symptoms clear up and return within a few days

Keep out of reach of children.

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

Directions

Other information

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Inactive Ingredients

benzyl alcohol, carbomer 940, chloesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate

Package Label

Manufactured for Ferndale Healthcare Inc.

Ferndale, MI 48220 U.S.A.

Toll free (888) 548-0900

www.ferndalehealthcare.com


L.M.X.5® is a registered trademark of Ferndale, IP Inc.
30 gram NDC 0496-0883-30

Carton

LMX5 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0883
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
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0496-0883-3030 g in 1 TUBE; Type 0: Not a Combination Product10/01/2003
2NDC:0496-0883-1515 g in 1 TUBE; Type 0: Not a Combination Product10/01/2003
3NDC:0496-0883-971 g in 1 POUCH; Type 0: Not a Combination Product10/01/2003
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01510/01/2003
Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIBusiness Operations
Ferndale Laboratories, Inc.005320536manufacture(0496-0883)

Revised: 12/2024
Document Id: 297a5049-0d6e-4e96-e063-6294a90a557d
Set id: 34f8ed6b-4a52-4a99-9c1b-254196dc29b0
Version: 4
Effective Time: 20241217
 
Ferndale Laboratories, Inc.