LMX4- 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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L.M.X.4

Active ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to

Warnings

For external use only.

Do not use

  • in or near the eyes
  • in large quantities, particularly over raw surfaces or blistered areas

Stop use and ask a doctor if:

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

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, trolamine, vitamin E acetate, water

Package Labels-Principal Display Panels

Manufactured by Ferndale Laboratories, Inc.

Ferndale, MI 48220 U.S.A.

Toll free (888) 548-0900

www.ferndalelabs.com

L.M.X.4® is a registered trademark of Ferndale IP, Inc.

Tegaderm™ is a trademark of 3M Corporation.


NDC 0496-0882-06 L.M.X.4® 5 x 5 grams

5x5gcarton


NDC 0496-0882-07 L.M.X.4® 5 x 5 grams with 10 3M Tegaderm™ Transparent Dressings

5x5gwtegadermcarton


NDC 0496-0882-15 L.M.X.4® 15 grams

15gcarton


NDC 0496-0882-30 L.M.X.4® 30 grams

30g

NDC 0496-0882-71 L.M.X.4® 30 grams with 10 3M Tegaderm™ Transparent Dressings

30gwtegadermcarton

NDC 0496-0882-05 L.M.X.4 5 grams

5g

LMX4 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0496-0882
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TROLAMINE (UNII: 9O3K93S3TK)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0496-0882-065 in 1 CARTON01/03/2011
1NDC:0496-0882-055 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0496-0882-075 in 1 BOX01/03/2011
2NDC:0496-0882-055 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0496-0882-1515 g in 1 TUBE; Type 0: Not a Combination Product01/03/2011
4NDC:0496-0882-3030 g in 1 TUBE; Type 0: Not a Combination Product01/03/2011
5NDC:0496-0882-055 g in 1 TUBE; Type 0: Not a Combination Product01/03/2011
6NDC:0496-0882-711 in 1 BOX01/03/2011
6NDC:0496-0882-3030 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/03/2011
Labeler - Ferndale Laboratories, Inc. (005320536)
Establishment
NameAddressID/FEIBusiness Operations
Ferndale Laboratories, Inc.005320536manufacture(0496-0882)

Revised: 5/2020
Document Id: a58a2e97-9b55-3b5a-e053-2995a90acb5a
Set id: f0e7c92f-8b0b-4045-b659-af9f6e81260f
Version: 4
Effective Time: 20200513
 
Ferndale Laboratories, Inc.