SPL v2
SPL
SPL Set ID 74120180-7653-6677-e053-2a91aa0ae122
Route
TOPICAL
Published
Effective Date 2013-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Water Vanillyl Butyl Ether

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2021-04-06

Description

Menthol


Medication Information

Warnings and Precautions

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children

Indications and Usage

Exercise before / after, except for sensitive areas, massage the appropriate amount as necessary

Dosage and Administration

for external use only

Description

Menthol

Section 50565-1

Keep out of reach of children.

Section 51727-6

Vanillyl Butyl Ether, Water, etc

Section 51945-4

Section 55105-1

Warming & Relaxing, Calming

Section 55106-9

Menthol


Structured Label Content

Indications and Usage (34067-9)

Exercise before / after, except for sensitive areas, massage the appropriate amount as necessary

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

1. Do not use in the following cases(Eczema and scalp wounds)

2.Side Effects

1)Due to the use of this druf if rash, irritation, itching and symptopms of hypersnesitivity occur dicontinue use and consult your phamacisr or doctor

3.General Precautions

1)If in contact with the eyes, wash out thoroughty with water If the symptoms are servere, seek medical advice immediately

2)This product is for exeternal use only. Do not use for internal use

4.Storage and handling precautions

1)If possible, avoid direct sunlight and store in cool and area of low humidity

2)In order to maintain the quality of the product and avoid misuse

3)Avoid placing the product near fire and store out in reach of children

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Vanillyl Butyl Ether, Water, etc

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Warming & Relaxing, Calming

Section 55106-9 (55106-9)

Menthol


Advanced Ingredient Data


Raw Label Data

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