0baa3842-79e2-9735-e063-6294a90ab4ea

SPL v1
SPL
SPL Set ID 0baa3842-79e2-9735-e063-6294a90ab4ea
Route
topical
Published
Effective Date 2023-12-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (10.5 g)
Inactive Ingredients
juniper berry calendula officinalis flower echinacea angustifolia isopropyl myristate chamomile ilex paraguariensis leaf vanilla methyl salicylate green tea leaf water caryophyllene alcohol arnica montana flower dimethyl sulfone

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2023-12-03

Purpose

Topical Analgesic

Description

Menthol 10.5%


Medication Information

Warnings

For external use only

Purpose

Topical Analgesic

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

Inactive Ingredients

Alcohol Denat, Arnica Montana Flower Extract, Beta-Caryophyllene(Clove), Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomile Recutita Flower Extract, Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Oil of Wintergreen, Vanilla Extract, Water

Description

Menthol 10.5%

Principal Display Panel

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

Questions

Phone: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

Do Not Use

While smoking or near heat or 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

Active Ingredient

Menthol 10.5%

Keep Oot of Reach of Children

If accidentally ingested get medical help or contact a Poison Control Center immediately


Structured Label Content

Warnings

For external use only

Purpose

Topical Analgesic

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

Inactive Ingredients (Inactive ingredients)

Alcohol Denat, Arnica Montana Flower Extract, Beta-Caryophyllene(Clove), Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomile Recutita Flower Extract, Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Oil of Wintergreen, Vanilla Extract, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

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

Questions

Phone: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

Do Not Use (Do not use)

While smoking or near heat or 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

Active Ingredient

Menthol 10.5%

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


Advanced Ingredient Data


Raw Label Data

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