Dermachange Cold Therapy Gel, Menthol 2%

Dermachange Cold Therapy Gel, Menthol 2%
SPL v1
SPL
SPL Set ID 12ef7dd8-3da3-9c87-e063-6394a90ac924
Route
TOPICAL
Published
Effective Date 2024-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (2 g)
Inactive Ingredients
Ammonia Fd&c Blue No. 1 Water Carbomer Interpolymer Type B (allyl Pentaerythritol Crosslinked) Copper Pidolate Propylene Glycol Magnesium Sulfate, Unspecified Form Isopropyl Alcohol Thymol Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-27

Description

Menthol 2%


Medication Information

Warnings and Precautions

For external use only.

Do not use with other topical pain relievers, with heating pad or heating devices.

When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days.

Indications and Usage

For the temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

Dosage and Administration

• adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. • Children under 12 years old, ask a doctor

Description

Menthol 2%

Section 50565-1

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Ammonium hydroxide, blue 1, carbomer, copper PCA, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water.

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

Menthol 2%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains associated with arthritis, simple backache, strains, sprains, and bruises.

Dosage and Administration (34068-7)

• adults and children 12 years and older, apply to affected area not more than 3 to 4 times daily. • Children under 12 years old, ask a doctor

Warnings and Precautions (34071-1)

For external use only.

Do not use with other topical pain relievers, with heating pad or heating devices.

When using this product do not use in or near the eyes, do not apply to wounds or damaged skin, do not bandage tightly.

Stop use and ask a doctor if condition worsens, symptoms last more than 7 days or clear and occur again within a few days.

Section 50565-1 (50565-1)

If product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Ammonium hydroxide, blue 1, carbomer, copper PCA, isopropyl alcohol, magnesium sulfate, sodium hydroxide, thymol, water.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

Menthol 2%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)