Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f3a142c8-05c5-7525-e053-2a95a90a920e
Route
TOPICAL
Published
Effective Date 2023-02-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (1 g)
Inactive Ingredients
Water Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2023-02-01

Description

menthol


Medication Information

Warnings and Precautions

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

Storage and handling precautions

If possible, avoid direct sunlight and store in cool and area of low humidity in order to maintain the quality of the product and avoid misuse

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

- consult a physician in case of abnormal symptoms, such as red spots, swelling or itching, or side effects in the areas of application due to direct light during or after using the product

- do not use on wounded area

Indications and Usage

Apply an appropriate amount as if massaging before and after exercise (except for the face and sensitive body parts)

Dosage and Administration

for external use only

Description

menthol

Section 50565-1

keep out or reach of the children

Section 51727-6

Water

Ethanol

Chamaecyparis Obtusa Water

Dipropylene Glycol

Glycerin

Illite Extract

Butylene Glycol

Vincetoxicum Atratum Extract

Sodium Polyacrylate

Laureth-7

C13-14 Isoalkane

Vanillyl Butyl Ether

Fragrance

Section 51945-4

Section 55105-1

therapy by warming & relaxing

Section 55106-9

menthol


Structured Label Content

Indications and Usage (34067-9)

Apply an appropriate amount as if massaging before and after exercise (except for the face and sensitive body parts)

Dosage and Administration (34068-7)

for external use only

Warnings and Precautions (34071-1)

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

Storage and handling precautions

If possible, avoid direct sunlight and store in cool and area of low humidity in order to maintain the quality of the product and avoid misuse

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

- consult a physician in case of abnormal symptoms, such as red spots, swelling or itching, or side effects in the areas of application due to direct light during or after using the product

- do not use on wounded area

Section 50565-1 (50565-1)

keep out or reach of the children

Section 51727-6 (51727-6)

Water

Ethanol

Chamaecyparis Obtusa Water

Dipropylene Glycol

Glycerin

Illite Extract

Butylene Glycol

Vincetoxicum Atratum Extract

Sodium Polyacrylate

Laureth-7

C13-14 Isoalkane

Vanillyl Butyl Ether

Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

therapy by warming & relaxing

Section 55106-9 (55106-9)

menthol


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)