84214-007

84214-007
SPL v1
SPL
SPL Set ID 1d1a2f4a-7b25-e595-e063-6394a90a00d5
Route
TOPICAL
Published
Effective Date 2024-07-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g) Lidocaine (4 g)
Inactive Ingredients
Alcohol Echinacea Angustifolia Hyaluronic Acid Calendula Officinalis Flower Citrus Fruit Juniper Berry Methyl Salicylate Caryophyllene Chamomile Green Tea Leaf Lavandula Angustifolia Flower Isopropyl Myristate Salix Alba Bark Arnica Montana Flower Dimethyl Sulfoxide Ilex Paraguariensis Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-13

Description

Menthol 1% Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Menthol 1% Lidocaine 4%

Use

Temporary relief from minor aches and pains of muscles and joints associated with arthritis, simple backache, strains 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

Questions

Call 1(888) 778-2986

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

While smoking or near heat or open flame

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

Active Ingredient

Menthol 1%

Lidocaine 4%

Inactive Ingredients

Alcohol Denat, Arnica Montana Flower Extract, Beta-Caryophyllene(Clove), Calendula Officinalis Flower, Chamomile Extract, Chorus Fruit Extract,Dimethyl Sulfoxide, Echinacea Angustifolia Extract, Green Tea Extract,Hyaluronic Acid,IIex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Lavender Extract, Water, White Willow Bark Extract, Oil of Wintergreen.

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.


Structured Label Content

Use

Temporary relief from minor aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains

Purpose

Topical Anesthetic

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

Questions

Call 1(888) 778-2986

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)

While smoking or near heat or open flame

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

Active Ingredient

Menthol 1%

Lidocaine 4%

Inactive Ingredients (Inactive ingredients)

Alcohol Denat, Arnica Montana Flower Extract, Beta-Caryophyllene(Clove), Calendula Officinalis Flower, Chamomile Extract, Chorus Fruit Extract,Dimethyl Sulfoxide, Echinacea Angustifolia Extract, Green Tea Extract,Hyaluronic Acid,IIex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Lavender Extract, Water, White Willow Bark Extract, Oil of Wintergreen.

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.


Advanced Ingredient Data


Raw Label Data

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