Drug Fact

Drug Fact
SPL v1
SPL
SPL Set ID 5b4e7f72-8845-492a-afab-30f2d4556384
Route
TOPICAL
Published
Effective Date 2013-10-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2.5 g)
Inactive Ingredients
Methyl Salicylate Water Alcohol Glycerin Polyoxyl 40 Hydrogenated Castor Oil Medium-chain Triglycerides Acrylamide Eugenol Methyl Eugenol Nutmeg Oil Methyl Isoeugenol Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2013-10-24

Description

Menthol 2.5%

Indications and Usage

Temporary relief of minor arthritis pain, backache, muscle strains, sprains, and mesntrual cramps. Apply generously and massage into the affected area until throughly absorbed into the skin,repeat as and when needed for pain but not more than 4 times a day.

Purpose

Temporary relief of minor arthritis pain, backache, muscle strains, sprains, and mesntrual cramps.

Dosage and Administration

Apply generously and massage into the affected area until throughly absorbed into the skin,repeat as and when needed for pain but not more than 4 times a day.


Medication Information

Indications and Usage

Temporary relief of minor arthritis pain, backache, muscle strains, sprains, and mesntrual cramps.

Apply generously and massage into the affected area until throughly absorbed into the skin,repeat as and when needed for pain but not more than 4 times a day.

Purpose

Temporary relief of minor arthritis pain, backache, muscle strains, sprains, and mesntrual cramps.

Dosage and Administration

Apply generously and massage into the affected area until throughly absorbed into the skin,repeat as and when needed for pain but not more than 4 times a day.

Description

Menthol 2.5%

Warnings

Keep out of reach of children.

For esternal use only, use only as directed.

Donot apply to wound or broken skin.

If redness present discontinue and consult a doctor.

Do not bandage tightly or use a heating pad.

If the condition persists for more than 5 days, discontinue use and consult a doctor.

Avoid contact with eyes and other mucous membranes.

If you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.

Active Ingredient

Menthol 2.5%

Inactive Ingredient.

Water

SD Alcohol

Glycerine

PEG-440 Hydrogenated Castor Oil

Methyl Salicylate

Caprylic Capric Triglyceride

Sodium Acrylate Copolymer

Eugenol

Methyl Eugenol

Nutmeg Oil

Methyllisoeugenol

Methoxy Eugenol

Blue # 1

Principal Display Panel

Dosage and Administration.

Apply generously and massage into the affected area until throughly absorbed into the skin,repeat as and when needed for pain but not more than 4 times a day.

Keep Out of Reach of Children


Structured Label Content

Purpose

Temporary relief of minor arthritis pain, backache, muscle strains, sprains, and mesntrual cramps.

Warnings

Keep out of reach of children.

For esternal use only, use only as directed.

Donot apply to wound or broken skin.

If redness present discontinue and consult a doctor.

Do not bandage tightly or use a heating pad.

If the condition persists for more than 5 days, discontinue use and consult a doctor.

Avoid contact with eyes and other mucous membranes.

If you are pregnant or nursing a baby, seek the advice of a healthcare professional before using this product.

Active Ingredient

Menthol 2.5%

Inactive Ingredient. (Inactive ingredient.)

Water

SD Alcohol

Glycerine

PEG-440 Hydrogenated Castor Oil

Methyl Salicylate

Caprylic Capric Triglyceride

Sodium Acrylate Copolymer

Eugenol

Methyl Eugenol

Nutmeg Oil

Methyllisoeugenol

Methoxy Eugenol

Blue # 1

Indications and Usage

Temporary relief of minor arthritis pain, backache, muscle strains, sprains, and mesntrual cramps.

Apply generously and massage into the affected area until throughly absorbed into the skin,repeat as and when needed for pain but not more than 4 times a day.

Principal Display Panel (Principal Display panel)

Dosage and Administration. (Dosage and administration.)

Apply generously and massage into the affected area until throughly absorbed into the skin,repeat as and when needed for pain but not more than 4 times a day.

Keep Out of Reach of Children (Keep out of reach of children)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)