Goodsense Cooling Pain Relief Gel

Goodsense Cooling Pain Relief Gel
SPL v2
SPL
SPL Set ID 2e5e1375-df07-9a43-e063-6394a90a9938
Route
TOPICAL
Published
Effective Date 2025-02-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4 g)
Inactive Ingredients
Water Isopropyl Alcohol Carbomer 940 Magnesium Sulfate Fd&c Blue No. 1 Fd&c Yellow No. 5 Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-17

Description

Menthol 4%


Medication Information

Warnings and Precautions

For external use only.

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water, avoid contact with broken skin, do not bandage tightly, and do not use with heating pad.

Stop use and ask a doctor if the condition worsens, rash or irritation develops and lasts for more than 7 days or clear up and occur again within a few days.

Indications and Usage

Adults and children 12 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 12 years of age: ask a doctor.

Dosage and Administration

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

Description

Menthol 4%

Section 50565-1

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, and yellow 5.

Section 51945-4

Section 53414-9

Ask a health professional before use.

Section 55105-1

Topical Analgesic.

Section 55106-9

Menthol 4%


Structured Label Content

Indications and Usage (34067-9)

Adults and children 12 years and older: apply to the affected area, not more than 3 to 4 times a day. Children under 12 years of age: ask a doctor.

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

For external use only.

When using this product keep out of eyes. In case of contact with eyes, flush thoroughly with water, avoid contact with broken skin, do not bandage tightly, and do not use with heating pad.

Stop use and ask a doctor if the condition worsens, rash or irritation develops and lasts for more than 7 days or clear up and occur again within a few days.

Section 50565-1 (50565-1)

Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Blue 1, carbomer, isopropyl alcohol, magnesium sulfate, sodium hydroxide, water, and yellow 5.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Ask a health professional before use.

Section 55105-1 (55105-1)

Topical Analgesic.

Section 55106-9 (55106-9)

Menthol 4%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)