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NDC 00496-0882-05 LMX4 40 mg/g Details

LMX4 40 mg/g

LMX4 is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Ferndale Laboratories, Inc.. The primary component is LIDOCAINE.

Product Information

NDC	00496-0882
Product ID	0496-0882_a58a2e97-9b55-3b5a-e053-2995a90acb5a
Associated GPIs	90850060003720 90859902896420
GCN Sequence Number	040262
GCN Sequence Number Description	lidocaine CREAM (G) 4 % TOPICAL
HIC3	Q5H
HIC3 Description	TOPICAL LOCAL ANESTHETICS
GCN	95405
HICL Sequence Number	010705
HICL Sequence Number Description	LIDOCAINE
Brand/Generic	Brand
Proprietary Name	LMX4
Proprietary Name Suffix	n/a
Non-Proprietary Name	lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	40
Active Ingredient Units	mg/g
Substance Name	LIDOCAINE
Labeler Name	Ferndale Laboratories, Inc.
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00496-0882-05 (00496088205)

Pricing Information	N/A
NDC Package Code	0496-0882-05
Billing NDC	00496088205
Package	5 g in 1 TUBE (0496-0882-05)
Marketing Start Date	2011-01-03
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f0e7c92f-8b0b-4045-b659-af9f6e81260f Details

Active ingredient

Lidocaine 4% w/w

Purpose

Topical anesthetic

Uses

temporarily relieves pain and itching due to

minor cuts
minor scrapes
minor burns
sunburn
minor skin irritations
insect bites

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

Adults and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day
Children under 2 years: Consult a doctor

Other Information

May be applied under occlusive dressing.
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, 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

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

INGREDIENTS AND APPEARANCE

LMX4

lidocaine cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0496-0882
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	40 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	01/03/2011

Labeler - Ferndale Laboratories, Inc. (005320536)

Name	Address	ID/FEI	Business Operations
Establishment
Ferndale Laboratories, Inc.		005320536	manufacture(0496-0882)

Revised: 5/2020

Document Id: a58a2e97-9b55-3b5a-e053-2995a90acb5a

Set id: f0e7c92f-8b0b-4045-b659-af9f6e81260f

Version: 4

Effective Time: 20200513