84214-002

84214-002
SPL v1
SPL
SPL Set ID 1d0b7b8f-9e5d-00f7-e063-6394a90af87c
Route
TOPICAL
Published
Effective Date 2024-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Lidocaine (4 g)
Inactive Ingredients
Artemisia Argyi Leaf Borneol Crocus Sativus Flower Vanillyl Butyl Ether Water Galectin-3 Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-12

Description

Lidocaine 4% Menthol 1%

Purpose

Topical Anesthetic Topical Analgesic


Medication Information

Purpose

Topical Anesthetic

Topical Analgesic

Description

Lidocaine 4% Menthol 1%

Use

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Stop Use

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Warnings

For external use only

Ask Doctor

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Directions

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily

·Children under 12 years of age:Consult physician

Do Not Use

do not use wiih heating pad or device

When Using

·avoid contact with the eyes or mucous membranes

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·wash hands after use with cool water

·do not use with heating pad or device

·spray product away from nose,eyes,and mouth

·do not use in large quantities, particularly over raw surfaces or blistered areas

Active Ingredient

Lidocaine 4%

Menthol 1%

Inactive Ingredients

Borneol, Carbohydrates, Ginger Extract, Mugwort Leaf Extract, Saffron Extract, Vanillyl butyl, Water

Principal Display Panel

Keep Oot of Reach of Children

If accidentally ingested, get medical help or contact a Poison Control Center immediately. Make sure to turn child safety spray lock to off position when not in use. If pregnant or breast-feeding, ask a healthcare professional before use.


Structured Label Content

Use

For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains

Purpose

Topical Anesthetic

Topical Analgesic

Stop Use

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Warnings

For external use only

Ask Doctor

if condition worsens, or if symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Directions

·Adults and children 12 years of age and older:Apply to affected area not more than 3 to 4 times daily

·Children under 12 years of age:Consult physician

Do Not Use (Do not use)

do not use wiih heating pad or device

When Using

·avoid contact with the eyes or mucous membranes

·do not apply to wounds or damaged skin

·do not apply to irritated skin

·do not bandage

·wash hands after use with cool water

·do not use with heating pad or device

·spray product away from nose,eyes,and mouth

·do not use in large quantities, particularly over raw surfaces or blistered areas

Active Ingredient

Lidocaine 4%

Menthol 1%

Inactive Ingredients (Inactive ingredients)

Borneol, Carbohydrates, Ginger Extract, Mugwort Leaf Extract, Saffron Extract, Vanillyl butyl, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

If accidentally ingested, get medical help or contact a Poison Control Center immediately. Make sure to turn child safety spray lock to off position when not in use. If pregnant or breast-feeding, ask a healthcare professional before use.


Advanced Ingredient Data


Raw Label Data

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