SPL v1
SPL
SPL Set ID 3dfb8e19-5dfc-85b2-e063-6294a90ac4eb
Route
TOPICAL
Published
Effective Date 2025-09-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (5 g)
Inactive Ingredients
Soybean Lecithin Emu Oil Glycerin Horse Chestnut Propylene Glycol Arnica Montana Flower Water Alpha-tocopherol Acetate Aqua

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-04

Description

Active Ingredients .......5% Menthol.


Medication Information

Warnings and Precautions

Warnings (For external use only)

For external use only

Indications and Usage

For the temporary relief of localized pain, itching or discomfort from minor skin irritations.

Dosage and Administration

When practical, clean the area within mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.

Children under 12 years of age, consult a doctor.

To use finger cots: roll one finger cot cover the finger. Gently squeeze cream on to the finger cot. Smooth a layer of the cream.

Description

Active Ingredients .......5% Menthol.

Section 50565-1

lf swallowed, get medical help. Do not use if allergic to any ingredients.

Section 50566-9

Stop using and ask a doctor if

Condition worsens or does not improve within 7 days

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness irritation, swelling, pain, or other symptoms develop or increase

Symptoms clear up and return within a few days.

Section 50567-7

·Do not get into the eyes.* Do not exceed recommended dosage unless directed by a doctor." Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Section 51727-6

Inactive Ingredients

Tocopheryl Acetate, Emu Oil. Propylene Glycol, Arnica, Glycerin, Menthol, Aescinus Hippocastanum (Horse Chestnut)Extract, Lecithin(Soybean)Curcuma Longa Extract, Aqua

Section 51945-4

Section 53414-9

lf pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Topical Analgesic

Section 55106-9

Active Ingredients .......5% Menthol.

Section 60561-8

Store at room temperature 59°-86°F(15-30°C).Avoid direct sunlight. Do not use if tamper-evident packaging has been breached or is missing.


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of localized pain, itching or discomfort from minor skin irritations.

Dosage and Administration (34068-7)

When practical, clean the area within mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.

Adults and children 12 years and older: apply externally to the affected area up to 4 times a day.

Children under 12 years of age, consult a doctor.

To use finger cots: roll one finger cot cover the finger. Gently squeeze cream on to the finger cot. Smooth a layer of the cream.

Warnings and Precautions (34071-1)

Warnings (For external use only)

For external use only

Section 50565-1 (50565-1)

lf swallowed, get medical help. Do not use if allergic to any ingredients.

Section 50566-9 (50566-9)

Stop using and ask a doctor if

Condition worsens or does not improve within 7 days

Allergic reaction occurs to ingredients in this product.

Symptom being treated does not subside or if redness irritation, swelling, pain, or other symptoms develop or increase

Symptoms clear up and return within a few days.

Section 50567-7 (50567-7)

·Do not get into the eyes.* Do not exceed recommended dosage unless directed by a doctor." Do not put this product into the rectum by using fingers or any mechanical device or applicator.

Section 51727-6 (51727-6)

Inactive Ingredients

Tocopheryl Acetate, Emu Oil. Propylene Glycol, Arnica, Glycerin, Menthol, Aescinus Hippocastanum (Horse Chestnut)Extract, Lecithin(Soybean)Curcuma Longa Extract, Aqua

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

lf pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredients .......5% Menthol.

Section 60561-8 (60561-8)

Store at room temperature 59°-86°F(15-30°C).Avoid direct sunlight. Do not use if tamper-evident packaging has been breached or is missing.


Advanced Ingredient Data


Raw Label Data

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