SPL v1
SPL
SPL Set ID 3b9868e0-4ddc-680d-e063-6294a90af67f
Route
TOPICAL
Published
Effective Date 2025-08-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Alpha-tocopherol Licorice Aloe Vera Leaf Jojoba Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-05

Description

Menthol 1%...Topical Anesthetic


Medication Information

Warnings and Precautions

Stop and ask a doctor

an allergic reaction occurslf symptoms such as redness, swelling, irritation, swelling, pain occur, or if the symptoms worsen

Indications and Usage

Do not use in large quantie,.bo not exceed the recommended da dosage unles directed by a docorDo notuse ifyou are alergictothe ingredients in this product or ifthe sea is broken ormising

Dosage and Administration

Children under 2 years: Do not useFor children under the age of 12, please consult a doctorFor adults:Apply to affected area not more than 3 times daily. lf possible, clean the affected area with mildsoap and warm water, and make sure to rinse thoroughly.Avoid applying to large areas of thebody Use only as directed,

Description

Menthol 1%...Topical Anesthetic

Section 50565-1

Keep out of reach of chidrenin case of accidental ingestion,seekmedical advice immediately or contact a Poison Control Center right away.

Section 50566-9

Stop and ask a doctor

an alergic reaction occurslf symptoms such as redness, swelling, irritation, swelling, pain occur, or if the symptoms worsen.

Section 51727-6

Aloe Vera Extract,Tocopherol (Vitamin E),Licorice Root Extract.Jojoba Seed Oil.

Section 51945-4

Section 55105-1

Temporarily relieves minor pain anditching associated with minor skin irritations.

Section 55106-9

Menthol 1%...Topical Anesthetic

Section 60561-8

Other Information

Storage and HandlingStore between 15-30°C(59-86"F)Avoid freezing and excessive heatabove 40°C(104°F)


Structured Label Content

Indications and Usage (34067-9)

Do not use in large quantie,.bo not exceed the recommended da dosage unles directed by a docorDo notuse ifyou are alergictothe ingredients in this product or ifthe sea is broken ormising

Dosage and Administration (34068-7)

Children under 2 years: Do not useFor children under the age of 12, please consult a doctorFor adults:Apply to affected area not more than 3 times daily. lf possible, clean the affected area with mildsoap and warm water, and make sure to rinse thoroughly.Avoid applying to large areas of thebody Use only as directed,

Warnings and Precautions (34071-1)

Stop and ask a doctor

an allergic reaction occurslf symptoms such as redness, swelling, irritation, swelling, pain occur, or if the symptoms worsen

Section 50565-1 (50565-1)

Keep out of reach of chidrenin case of accidental ingestion,seekmedical advice immediately or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop and ask a doctor

an alergic reaction occurslf symptoms such as redness, swelling, irritation, swelling, pain occur, or if the symptoms worsen.

Section 51727-6 (51727-6)

Aloe Vera Extract,Tocopherol (Vitamin E),Licorice Root Extract.Jojoba Seed Oil.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Temporarily relieves minor pain anditching associated with minor skin irritations.

Section 55106-9 (55106-9)

Menthol 1%...Topical Anesthetic

Section 60561-8 (60561-8)

Other Information

Storage and HandlingStore between 15-30°C(59-86"F)Avoid freezing and excessive heatabove 40°C(104°F)


Advanced Ingredient Data


Raw Label Data

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