83822-003

83822-003
SPL v1
SPL
SPL Set ID 145f7499-b92c-f953-e063-6294a90a36e4
Route
TOPICAL
Published
Effective Date 2024-03-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g) Lidocaine (4 g)
Inactive Ingredients
Water Methyl Salicylate Tartaric Acid Alcohol Edetic Acid Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Capsicum Sodium Polyacrylate (2500000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-24

Description

Lidocaine 4% Menthol 3%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4% Menthol 3%

Use

for the temporary relief of pain

Stop Use

·condition worsens or symptoms persist for more than 7 days

·symptoms clear up and occur again within a few days

·severe burning sensation,redness or irritation develops

·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied

Warnings

For external use only

Ask Doctor

·condition worsens or symptoms persist for more than 7 days

·symptoms clear up and occur again within a few days

·severe burning sensation,redness or irritation develops

·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied

Directions

Adults and children 12 years of age and older:

-clean and dry affected area

-remove backing from patch by firmly grasping both ends and gently pulling until backing seprarates in middle

-carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

-once exposed portion of the patch is positioned,carefully remove remaining backing to completely apply patch

to affected area - use 1 patch at a time and not more than 3 to 4 times daily

Children under 12 years of age: consult a doctor

Do Not Use

·on puncture wounds,cuts,irritated,damaged or swollwn skin

·more than 1 patch on your body at a time or with other topical analgesics at the same time

·with a heating pad or apply local heat to the area of use

When Using

·use only as directed

·do not bandage tightly

·avoid contact with eyes and mucous membranes

·rare cases of serious burns have been reported with products of this type

·a transient burning sensation may occur upon application but generally disappears in several days

·dispose of used patch in manner that always keeps products away from children and pets.Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Active Ingredient

Lidocaine 4%

Menthol 3%

Inactive Ingredients

Aluminum glycinate, chili extract, EDTA-2NA, ethanol, glycerol, sodium polyacrylate, tartaric acid,

water, wintergreen oil

Principal Display Panel

Keep Oot of Reach of Children

If swallowed, get medical help or contact a poison control center right away.


Structured Label Content

Use

for the temporary relief of pain

Purpose

Topical anesthetic

Stop Use

·condition worsens or symptoms persist for more than 7 days

·symptoms clear up and occur again within a few days

·severe burning sensation,redness or irritation develops

·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied

Warnings

For external use only

Ask Doctor

·condition worsens or symptoms persist for more than 7 days

·symptoms clear up and occur again within a few days

·severe burning sensation,redness or irritation develops

·you experience signs of skin injury,such as pain,swelling,or blistering where the product was applied

Directions

Adults and children 12 years of age and older:

-clean and dry affected area

-remove backing from patch by firmly grasping both ends and gently pulling until backing seprarates in middle

-carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

-once exposed portion of the patch is positioned,carefully remove remaining backing to completely apply patch

to affected area - use 1 patch at a time and not more than 3 to 4 times daily

Children under 12 years of age: consult a doctor

Do Not Use (Do not use)

·on puncture wounds,cuts,irritated,damaged or swollwn skin

·more than 1 patch on your body at a time or with other topical analgesics at the same time

·with a heating pad or apply local heat to the area of use

When Using

·use only as directed

·do not bandage tightly

·avoid contact with eyes and mucous membranes

·rare cases of serious burns have been reported with products of this type

·a transient burning sensation may occur upon application but generally disappears in several days

·dispose of used patch in manner that always keeps products away from children and pets.Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Active Ingredient

Lidocaine 4%

Menthol 3%

Inactive Ingredients (Inactive ingredients)

Aluminum glycinate, chili extract, EDTA-2NA, ethanol, glycerol, sodium polyacrylate, tartaric acid,

water, wintergreen oil

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Oot of Reach of Children (Keep Oot Of Reach Of Children)

If swallowed, get medical help or contact a poison control center right away.


Advanced Ingredient Data


Raw Label Data

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