Pain Relief Liquid Spray

Pain Relief Liquid Spray
SPL v3
SPL
SPL Set ID b4dfa5fa-2d61-db1e-e053-2a95a90a7ac8
Route
TOPICAL
Published
Effective Date 2020-11-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 g)
Inactive Ingredients
Calendula Arvensis Leaf Propylene Glycol Water Glycerin Aloe Vera Leaf Alcohol Ilex Paraguariensis Leaf Matricaria Chamomilla Flowering Top Oil Echinacea Angustifolia Arnica Montana Flower Juniper Berry Green Tea Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-11-30
Description

Menthol 16%

Medication Information

Warnings and Precautions

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Indications and Usage

For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

Dosage and Administration

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Description

Menthol 16%

Section 50565-1

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

Section 51727-6

Alcohol Denat., Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Propylene Glycol, Water

Section 51945-4

Section 53414-9

If pregnant or breast-feeding ask a health professional.

Section 55105-1



Topical Analgesic

Section 55106-9

Menthol 16%

Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pain associated with simple backaches, arthritis, strains, bruises, and sprains.

Dosage and Administration (34068-7)

Shake well before use. Adults and children 12 years of age and older, apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age: ask a doctor.

Warnings and Precautions (34071-1)

For external use only. Flammable--Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact with eyes, flush thoroughly with water, do not apply to wounds or damaged skin, and do not bandage tightly, do not use with a heating pad. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F. . Stop use and ask a doctor if condition worsens, if symptoms persist for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Alcohol Denat., Aloe Barbadensis (Aloe Vera) Leaf Extract, Arnica Montana (Arnica) Flower Extract, Calendula Officinalis (Marigold) Flower Extract, Camellia Sinensis (Green Tea) Leaf Extract, Echinacea Angustifolia (Coneflower) Extract, Glycerin, Ilex Paraguariensis (Yerba Mate) Leaf Extract, Juniperus Communis (Juniper) Fruit Extract, Propylene Glycol, Water

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding ask a health professional.

Section 55105-1 (55105-1)



Topical Analgesic

Section 55106-9 (55106-9)

Menthol 16%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:50.541896 · Updated: 2026-03-14T23:05:54.616139