85056-001

85056-001
SPL v2
SPL
SPL Set ID 29aefb41-bf5b-1c3c-e063-6294a90a9570
Route
CUTANEOUS
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Lidocaine (4 g)
Inactive Ingredients
Water Pvp Glycerin Sodium Polyacrylate (8000 Mw) Dihydroxyaluminum Aminoacetate Methylparaben Propylparaben Alcohol Tartaric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-18

Description

Lidocaine 4% Menthol 1%

Purpose

Topical Analgesic Pain Relief


Medication Information

Purpose

Topical Analgesic

Pain Relief



Description

Lidocaine 4% Menthol 1%

Use

Temporarily relieves muscle soreness and minor joint pains

in the wrist, knees, back, neck, hips, shoulders, elbows.



Section 50565-1

Keep out of reach of children.

Section 50566-9

if skin reactions such as redness, swelling, blistering or other discomfort occur symptoms persist for more than 7 days

If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children.

If swallowed accidentally , get medical help or contact with Poison Control Center immediately



Section 50567-7

use only as directed. avoid contact with the eyes, mucous membranes, or rashes

do not bandage tightly



Section 51945-4

Warnings

For external use only.

Directions

Adults and children above 12 years old;

Clean and dry the affected area.

Tear off the protective film and apply the exposed part of the patch to the the affected area.

Carefully remove remaining film while pressing the patch firmly on the skin.

Remove patch from the skin after at most 8 hours application.

Children under age of 12:C onsult a doctor



Do Not Use

on wounds or damaged skin with a heating pad or device with other ointments, creams, sprays, or liniments

if your are allergic to any ingredients of this product



Other Information

No Data

Active Ingredient(s)

Lidocaine 4%

Menthol 1%

Inactive Ingredients

Glycerine、Alcohol、 Aluminium glycinate、Sodium Polyacrylate、Pvpk-90、

Tartaric acid Propylparaben、 Methylparaben、 Water




Structured Label Content

Use

Temporarily relieves muscle soreness and minor joint pains

in the wrist, knees, back, neck, hips, shoulders, elbows.



Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

if skin reactions such as redness, swelling, blistering or other discomfort occur symptoms persist for more than 7 days

If pregnant or breast-feeding ask a health professional before use. Keep out of reach of children.

If swallowed accidentally , get medical help or contact with Poison Control Center immediately



Section 50567-7 (50567-7)

use only as directed. avoid contact with the eyes, mucous membranes, or rashes

do not bandage tightly



Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Pain Relief



Warnings

For external use only.

Directions

Adults and children above 12 years old;

Clean and dry the affected area.

Tear off the protective film and apply the exposed part of the patch to the the affected area.

Carefully remove remaining film while pressing the patch firmly on the skin.

Remove patch from the skin after at most 8 hours application.

Children under age of 12:C onsult a doctor



Do Not Use (Do not use)

on wounds or damaged skin with a heating pad or device with other ointments, creams, sprays, or liniments

if your are allergic to any ingredients of this product



Other Information (Other information)

No Data

Active Ingredient(s)

Lidocaine 4%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

Glycerine、Alcohol、 Aluminium glycinate、Sodium Polyacrylate、Pvpk-90、

Tartaric acid Propylparaben、 Methylparaben、 Water




Advanced Ingredient Data


Raw Label Data

All Sections (JSON)