Label: LMX4- lidocaine cream
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NDC Code(s):
0496-0882-05,
0496-0882-06,
0496-0882-07,
0496-0882-15, view more0496-0882-30, 0496-0882-71
- Packager: Ferndale Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated May 13, 2020
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
- Warnings
- Keep out of reach of children.
- Directions
- Other Information
- Inactive ingredients
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Package Labels-Principal Display Panels
Manufactured by Ferndale Laboratories, Inc.
Ferndale, MI 48220 U.S.A.
Toll free (888) 548-0900
www.ferndalelabs.comL.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
NDC 0496-0882-07 L.M.X.4® 5 x 5 grams with 10 3M Tegaderm™ Transparent Dressings
NDC 0496-0882-15 L.M.X.4® 15 grams
NDC 0496-0882-30 L.M.X.4® 30 grams
NDC 0496-0882-71 L.M.X.4® 30 grams with 10 3M Tegaderm™ Transparent Dressings
NDC 0496-0882-05 L.M.X.4 5 grams
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INGREDIENTS AND APPEARANCE
LMX4
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0496-0882 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 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:0496-0882-06 5 in 1 CARTON 01/03/2011 1 NDC:0496-0882-05 5 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0496-0882-07 5 in 1 BOX 01/03/2011 2 NDC:0496-0882-05 5 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0496-0882-15 15 g in 1 TUBE; Type 0: Not a Combination Product 01/03/2011 4 NDC:0496-0882-30 30 g in 1 TUBE; Type 0: Not a Combination Product 01/03/2011 5 NDC:0496-0882-05 5 g in 1 TUBE; Type 0: Not a Combination Product 01/03/2011 6 NDC:0496-0882-71 1 in 1 BOX 01/03/2011 6 NDC:0496-0882-30 30 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 01/03/2011 Labeler - Ferndale Laboratories, Inc. (005320536) Establishment Name Address ID/FEI Business Operations Ferndale Laboratories, Inc. 005320536 manufacture(0496-0882)