Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID f1daa68d-1b12-c28a-e053-2995a90a0949
Route
TOPICAL
Published
Effective Date 2018-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (10.5 g)
Inactive Ingredients
Alcohol Arnica Montana Flower Calendula Officinalis Flower Green Tea Leaf Matricaria Recutita Flowering Top Dimethyl Sulfone Echinacea Angustifolia Ilex Paraguariensis Leaf Isopropyl Myristate Juniper Berry Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-09

Description

Active ingredient Purpose Menthol 10.5%..............................................................Cooling Pain Relief


Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable: Do not use while smoking or near heat or flame.

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

membranes • do not apply to wounds or damaged skin • do not apply

to the irritated skin • do not bandage • wash hands after use with cool

water • do not use with heating pad or device

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

persist for more than 7 days, or clear up and reoccur.

Indications and Usage

Uses Temporary relief from minor aches and pains of sore muscles and

joints associated with arthritis, backache, strains and sprains

Dosage and Administration

Directions • Adults and children 12 years of age and older: Spray to affected area not more than 4 times daily.

• Children under 12 years of age: Consult physician.

Description

Active ingredient Purpose Menthol 10.5%..............................................................Cooling Pain Relief

Section 50565-1

Keep out of reach of children. If accidentally ingested get medical help or contact a Poison Control Center immediately

Section 51727-6

Inactive ingredients Alcohol Denat., Arnica Montana Flower

Extract, 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, Water

Section 51945-4

Section 55105-1

Cooling Pain relief

Section 55106-9

Active ingredient Purpose



Menthol 10.5%..............................................................Cooling Pain Relief


Structured Label Content

Indications and Usage (34067-9)

Uses Temporary relief from minor aches and pains of sore muscles and

joints associated with arthritis, backache, strains and sprains

Dosage and Administration (34068-7)

Directions • Adults and children 12 years of age and older: Spray to affected area not more than 4 times daily.

• Children under 12 years of age: Consult physician.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Flammable: Do not use while smoking or near heat or flame.

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

membranes • do not apply to wounds or damaged skin • do not apply

to the irritated skin • do not bandage • wash hands after use with cool

water • do not use with heating pad or device

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

persist for more than 7 days, or clear up and reoccur.

Section 50565-1 (50565-1)

Keep out of reach of children. If accidentally ingested get medical help or contact a Poison Control Center immediately

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, Dimethyl Sulfone, Echinacea

Angustifolia Extract, Ilex Paraguariensis Leaf Extract, Isopropyl Myristate,

Juniperus Communis Fruit Extract, Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Cooling Pain relief

Section 55106-9 (55106-9)

Active ingredient Purpose



Menthol 10.5%..............................................................Cooling Pain Relief


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)