LMX5 - lidocaine cream 
Ferndale Laboratories, 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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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

  • When practical, clean area with mild soap and warm water and rinse thoroughly.  Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • Adults and Children 12 years and older:  Apply to the affected area up to 6 times a day.
  • Children under 12 years of age:  Consult a doctor.

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, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate.

Package Label

Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A
Toll free (888) 548-0900
www.ferndalelabs.com
L.M.X.5® is a registered trademark of Ferndale, IP Inc.

30 gram NDC 0496-0883-30
30gramCarton

LMX5 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0883
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (LIDOCAINE) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
CARBOMER HOMOPOLYMER TYPE C 
CHOLESTEROL 
LECITHIN, SOYBEAN 
ISOPROPYL MYRISTATE 
POLYSORBATE 80 
PROPYLENE GLYCOL 
WATER 
TROLAMINE 
ALPHA-TOCOPHEROL ACETATE 
Packaging
#Item CodePackage Description
1NDC:0496-0883-3030 g in 1 TUBE
2NDC:0496-0883-1515 g in 1 TUBE
3NDC:0496-0883-971 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34610/01/2003
Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIBusiness Operations
Ferndale Laboratories, Inc.005320536manufacture

Revised: 01/2012
Document Id: 140234c1-b36b-4b64-9177-522e9e635234
Set id: 34f8ed6b-4a52-4a99-9c1b-254196dc29b0
Version: 1
Effective Time: 20120101
 
Ferndale Laboratories, Inc.