SPL v1
SPL
SPL Set ID 214eff56-03ad-68ec-e063-6394a90a3f93
Route
TOPICAL
Published
Effective Date 2024-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10.5 g)
Inactive Ingredients
Arnica Montana Flower Indian Frankincense Green Tea Leaf Hyaluronate Sodium Carya Ovata Bark Citric Acid Monohydrate Alcohol Glucosamine Sulfate Propylene Glycol Chamomile Juniper Berry Phenoxyethanol Boric Acid Calendula Officinalis Flower Elosulfase Alfa Isopropyl Myristate Ilex Paraguariensis Leaf Water Dimethyl Sulfone Echinacea Angustifolia Fragrance 13576

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-04
Description

Menthol ........ 10.5%

Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

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

Dosage and Administration

Directions • For adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily

Description

Menthol ........ 10.5%

Section 50565-1

Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9

Stop use and ask doctor if • condition worsens, or if symptoms persist for

more than 7 days, or clear up and reoccur again within a few days

Section 50567-7

When using this product • avoid any contact with the eyes or mucous

membranes • flush with cold water if accidentally sprayed in eyes • 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 •

contents under pressure • do not puncture or incinerate • do not use if you are

allergic to any ingredient in Flexium • do not store at temperature above 120° F

Section 51727-6

Inactive ingredients Alcohol Denat., Arnica Montana Flower Extract, Calendula

Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomile Recutita Flower Extract,

CurcuTame™ Blend [Tamarind (Tamarindus Indica) Extract (Seed), Turmeric (Curcuma Longa)

Extract (Rhizome), Glucosamine Sulfate, Boron Citrate, Hyaluronic Acid, Chondroitin Sulfate,

Boswellia Serrata Extract (Gum Resin), Marine Type II Collagen (from Salmon)],

Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf

Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Section 51945-4

Section 53413-1

Question? 888-353-1205

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol ........ 10.5%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

Directions • For adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily

Warnings and Precautions (34071-1)

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children • If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9 (50566-9)

Stop use and ask doctor if • condition worsens, or if symptoms persist for

more than 7 days, or clear up and reoccur again within a few days

Section 50567-7 (50567-7)

When using this product • avoid any contact with the eyes or mucous

membranes • flush with cold water if accidentally sprayed in eyes • 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 •

contents under pressure • do not puncture or incinerate • do not use if you are

allergic to any ingredient in Flexium • do not store at temperature above 120° F

Section 51727-6 (51727-6)

Inactive ingredients Alcohol Denat., Arnica Montana Flower Extract, Calendula

Officinalis Flower Extract, Camellia Sinensis Leaf Extract, Chamomile Recutita Flower Extract,

CurcuTame™ Blend [Tamarind (Tamarindus Indica) Extract (Seed), Turmeric (Curcuma Longa)

Extract (Rhizome), Glucosamine Sulfate, Boron Citrate, Hyaluronic Acid, Chondroitin Sulfate,

Boswellia Serrata Extract (Gum Resin), Marine Type II Collagen (from Salmon)],

Dimethyl Sulfone, Echinacea Angustifolia Extract, Ilex Paraguariensis Leaf

Extract, Isopropyl Myristate, Juniperus Communis Fruit Extract, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Question? 888-353-1205

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol ........ 10.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:31.742369 · Updated: 2026-03-14T23:03:39.501835