SPL v1
SPL
SPL Set ID 3afeead3-4f5c-4711-e063-6294a90aacca
Route
TOPICAL
Published
Effective Date 2025-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1.8 g) Lidocaine (5 g)
Inactive Ingredients
Sodium Polyacrylate (2500000 Mw) Water Polyvinyl Alcohol Glycerin Aluminum Zirconium Trichlorohydrex Gly Edetate Disodium Tartaric Acid Glucosamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-28

Description

Lidocaine 4% Menthol 1.8%


Medication Information

Warnings and Precautions

WarningsFor external use only.

Indications and Usage

Directions

Adults and children 12 years of age and over: Clean and dry affected area,free of lotions, ointments and creams.Carefully remove backing starting at a corner.Apply sticky side of patch to affected area. Do not use more than onepatch in a 12 hourperiod. Repeat as necessary. Maximum 2 patches per day. Discard patch after singleuse.Children under 12 years of age: consult a physician.

Dosage and Administration

Maximum 2 patches per day. Discard patch after singleuse.Children under 12 years of age: consult a physician.

Description

Lidocaine 4% Menthol 1.8%

Section 50565-1

Keep out of reach of children and pets. lf swallowed, get medical help or contacta Poison Control Center(1-800-222-1222)right away.

Section 51727-6

Purified water

g1 ycerol

Glucosamine

polyving akohol

Tartaric acid

Disodium edetate dihydrate

Aluminium glycinat

Sodium polyacrylate

Section 51945-4

Section 55105-1

Temporarily relieves minor aches and pains of muscles and joints associated with:

msimple backache marthritis mstrains mbruises msprains

Section 55106-9

Lidocaine 4%

Menthol 1.8%

Section 60561-8

Otherinformation

Store in a clean, dry place outside of direct sunlight, Protect from excessive moisture.


Structured Label Content

Indications and Usage (34067-9)

Directions

Adults and children 12 years of age and over: Clean and dry affected area,free of lotions, ointments and creams.Carefully remove backing starting at a corner.Apply sticky side of patch to affected area. Do not use more than onepatch in a 12 hourperiod. Repeat as necessary. Maximum 2 patches per day. Discard patch after singleuse.Children under 12 years of age: consult a physician.

Dosage and Administration (34068-7)

Maximum 2 patches per day. Discard patch after singleuse.Children under 12 years of age: consult a physician.

Warnings and Precautions (34071-1)

WarningsFor external use only.

Section 50565-1 (50565-1)

Keep out of reach of children and pets. lf swallowed, get medical help or contacta Poison Control Center(1-800-222-1222)right away.

Section 51727-6 (51727-6)

Purified water

g1 ycerol

Glucosamine

polyving akohol

Tartaric acid

Disodium edetate dihydrate

Aluminium glycinat

Sodium polyacrylate

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Temporarily relieves minor aches and pains of muscles and joints associated with:

msimple backache marthritis mstrains mbruises msprains

Section 55106-9 (55106-9)

Lidocaine 4%

Menthol 1.8%

Section 60561-8 (60561-8)

Otherinformation

Store in a clean, dry place outside of direct sunlight, Protect from excessive moisture.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)