Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 60d16dbe-4dd5-a9f5-e053-2991aa0a4629
Route
TOPICAL
Published
Effective Date 2016-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g)
Inactive Ingredients
Eucalyptus Globulus Leaf Camphor, (-)- Arnica Montana Flower Witch Hazel Aloe Vera Leaf N-acetylglucosamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2017-12-01

Description

MENTHOL


Medication Information

Warnings and Precautions

Avoid contact with eyes. Stop if irritation occurs. Avoid bandaging tightly. Keep out of reach of children. Ask your doctor before use if pregnant or breast feeding

Indications and Usage

1. Apply gel on to affected areas.

2. Massage until completely absorbed into skin.

3. Repeat as many as needed.

* It is recommended to control the amount and times of use depending on your symptom.

Dosage and Administration

for external use only



Description

MENTHOL

Section 50565-1

keep out of reach of the children



Section 51727-6

Camphor, Carbomer, Eucalyptus Globulus Leaf Oil, Witch Hazel Extract, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Acetyl Glucosamine, etc.

Section 51945-4

Section 55105-1

External Analgesic: Multi Action Recovery for Warm Up & Cool Down

Section 55106-9

MENTHOL


Structured Label Content

Indications and Usage (34067-9)

1. Apply gel on to affected areas.

2. Massage until completely absorbed into skin.

3. Repeat as many as needed.

* It is recommended to control the amount and times of use depending on your symptom.

Dosage and Administration (34068-7)

for external use only



Warnings and Precautions (34071-1)

Avoid contact with eyes. Stop if irritation occurs. Avoid bandaging tightly. Keep out of reach of children. Ask your doctor before use if pregnant or breast feeding

Section 50565-1 (50565-1)

keep out of reach of the children



Section 51727-6 (51727-6)

Camphor, Carbomer, Eucalyptus Globulus Leaf Oil, Witch Hazel Extract, Arnica Montana Flower Extract, Aloe Barbadensis Leaf Extract, Acetyl Glucosamine, etc.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

External Analgesic: Multi Action Recovery for Warm Up & Cool Down

Section 55106-9 (55106-9)

MENTHOL


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)