SPL v1
SPL
SPL Set ID 3762701d-2420-4416-e063-6394a90ad97f
Route
TOPICAL
Published
Effective Date 2025-06-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (20 mg) Menthol (40 mg)
Inactive Ingredients
Curcuma Longa (turmeric) Root Powder Dimethyl Sulfone Cannabis Sativa Seed Oil Arnica Montana Flower Eucalyptus Globulus Leaf Oil Magnesium Chloride Lavandula Angustifolia (lavender) Oil Phenoxyethanol Boswellia Serrata Gum Alpha-tocopherol Acetate Sorbic Acid Water

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-06-12

Description

Adults and children 12 years and older: apply to affected area not more than 3–4 times daily Children under 12: ask a doctor


Medication Information

Description

Adults and children 12 years and older: apply to affected area not more than 3–4 times daily Children under 12: ask a doctor

Warnings

Warnings

For external use only.

Do Not Use

on wounds or damaged skin

When using this product

avoid contact with eyes

do not bandage tightly

Stop use and ask a doctor if:

condition worsens

symptoms persist for more than 7 days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and older: apply to affected area not more than 3–4 times daily

Children under 12: ask a doctor

Active Ingredients

Menthol 4%.............................External analgesic

Camphor 2%...........................External analgesic

Inactive Ingredient

Body butter base,

MSM,

magnesium chloride,

hemp seed oil,

arnica extract,

turmeric,

boswellia,

vitamin E,

eucalyptus oil,

lavender oil,

sorbic acid,

phenoxyethanol,

RO water

Indications & Usage

“For the temporary relief of minor aches and pains of muscles and joints associated with backaches, arthritis, strains, sprains, and bruises.”

Product Label Image

Keep Out of Reach of Children

If swallowed, get medical help or

contact a Poison Control Center right away.


Structured Label Content

Warnings

Warnings

For external use only.

Do Not Use

on wounds or damaged skin

When using this product

avoid contact with eyes

do not bandage tightly

Stop use and ask a doctor if:

condition worsens

symptoms persist for more than 7 days

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 12 years and older: apply to affected area not more than 3–4 times daily

Children under 12: ask a doctor

Active Ingredients (Active ingredients)

Menthol 4%.............................External analgesic

Camphor 2%...........................External analgesic

Inactive Ingredient (Inactive ingredient)

Body butter base,

MSM,

magnesium chloride,

hemp seed oil,

arnica extract,

turmeric,

boswellia,

vitamin E,

eucalyptus oil,

lavender oil,

sorbic acid,

phenoxyethanol,

RO water

Indications & Usage

“For the temporary relief of minor aches and pains of muscles and joints associated with backaches, arthritis, strains, sprains, and bruises.”

Product Label Image

Keep Out of Reach of Children (Keep out 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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