SPL v1
SPL
SPL Set ID 3dcf7978-8fc6-63cb-e063-6294a90ac385
Route
TOPICAL
Published
Effective Date 2025-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Lidocaine (4 g)
Inactive Ingredients
Tartaric Acid Povidone K90 Dihydroxyaluminum Aminoacetate Methylparaben Propylparaben Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-02
Description

Lidocaine 4%4 Menthol 1%

Medication Information

Warnings and Precautions

WARNINGS:For external use only

Indications and Usage



use only as directed.avoid contact with the eyes, mucous membranes,orrashesdo not bandagetightily

Dosage and Administration

Adults and children above 12 years old;

Clean and dry the affected area.Tear off the protective film and apply the exposed part ofthe patch to the affected area.

Carefullyremove remainingfilm while pressing the patch firmly on the skin.Remove patch from the skin after at most 12 hours application.Children under age of 12:Consult a doctor

Description

Lidocaine 4%4 Menthol 1%

Section 50565-1

Keep out of reach ofchildren.

lf swallowed accidentally, get medical help or contact with Poison ControlCenterimmediately

Section 50570-1

DO NOT USE:

On wounds or damaged skin with a heating pad or device with otherointments.creams,sprays,orlinimentsifyour are allergic to anying redients ofthis product

Section 51727-6

INGREDIENTS:

Glycerine Alcohol.Aluminium glycinate,Sodium Polyacrylate.Pvpk-90.Tartaricacid、Propyiparaben、Methylparaben、Water

Section 51945-4

Section 55105-1

USES:Temporarily relieves muscle soreness and minorjoint painsin thewrist,knees,back,neck,hips,shoulders,elbows.

Section 55106-9

Lidocaine 4%4

Menthol 1%

Structured Label Content

Indications and Usage (34067-9)



use only as directed.avoid contact with the eyes, mucous membranes,orrashesdo not bandagetightily

Dosage and Administration (34068-7)

Adults and children above 12 years old;

Clean and dry the affected area.Tear off the protective film and apply the exposed part ofthe patch to the affected area.

Carefullyremove remainingfilm while pressing the patch firmly on the skin.Remove patch from the skin after at most 12 hours application.Children under age of 12:Consult a doctor

Warnings and Precautions (34071-1)

WARNINGS:For external use only

Section 50565-1 (50565-1)

Keep out of reach ofchildren.

lf swallowed accidentally, get medical help or contact with Poison ControlCenterimmediately

Section 50570-1 (50570-1)

DO NOT USE:

On wounds or damaged skin with a heating pad or device with otherointments.creams,sprays,orlinimentsifyour are allergic to anying redients ofthis product

Section 51727-6 (51727-6)

INGREDIENTS:

Glycerine Alcohol.Aluminium glycinate,Sodium Polyacrylate.Pvpk-90.Tartaricacid、Propyiparaben、Methylparaben、Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

USES:Temporarily relieves muscle soreness and minorjoint painsin thewrist,knees,back,neck,hips,shoulders,elbows.

Section 55106-9 (55106-9)

Lidocaine 4%4

Menthol 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:54.409833 · Updated: 2026-03-14T23:09:57.827589