L.m.x.4 - DailyMed Details

L.m.x.4

SPL v6

SPL

SPL Set ID f0e7c92f-8b0b-4045-b659-af9f6e81260f

Route

TOPICAL

Published

Effective Date 2011-01-03

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Lidocaine (40 mg)

Inactive Ingredients

Benzyl Alcohol Carbomer Homopolymer Type C Cholesterol Polysorbate 80 Propylene Glycol Trolamine Alpha-tocopherol Acetate Water

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2011-01-03

Description

Lidocaine 4% w/w

Purpose

Topical anesthetic

Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4% w/w

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.

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

Do Not Use

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

Active Ingredient

Lidocaine 4% w/w

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 homopolymer, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate

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.

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

Structured Label Content

Uses

temporarily relieves pain and itching due to

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

Purpose

Topical anesthetic

Warnings

For external use only.

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

Do Not Use (Do not use)

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

Active Ingredient (Active ingredient)

Lidocaine 4% w/w

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 (Inactive ingredients)

benzyl alcohol, carbomer homopolymer, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate

Stop Use and Ask A Doctor If: (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. (Keep out of reach of children.)

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

Package Labels Principal Display Panels (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

Advanced Ingredient Data

[{"name": "BENZYL ALCOHOL", "unii": "LKG8494WBH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CARBOMER HOMOPOLYMER TYPE C", "unii": "4Q93RCW27E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHOLESTEROL", "unii": "97C5T2UQ7J", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TROLAMINE", "unii": "9O3K93S3TK", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ALPHA-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "LIDOCAINE", "unii": "98PI200987", "classCode": "ACTIB", "strengthNumerator": "40", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves pain and itching due to minor cuts minor scrapes minor burns sunburn minor skin irritations insect bites", "Purpose": "Topical anesthetic", "Warnings": "For external use only.", "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", "Do not use": "in or near the eyes in large quantities, particularly over raw surfaces or blistered areas", "Active ingredient": "Lidocaine 4% w/w", "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 homopolymer, cholesterol, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water, trolamine, and vitamin E acetate", "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.", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:47.591601 · Updated: 2026-03-14T23:11:35.907821