Equate Cool & Heat Pain Relief

Equate Cool & Heat Pain Relief
SPL v6
SPL
SPL Set ID ad156685-3bd5-6837-e053-2995a90ac788
Route
TOPICAL
Published
Effective Date 2025-12-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (16 mg)
Inactive Ingredients
Glycerin Water (c10-c30)alkyl Methacrylate Ester Propylene Glycol Trolamine Alcohol Capsaicin Isopropyl Myristate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-17

Description

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor.


Medication Information

Warnings and Precautions

Flammable, keep away from fire or flame. When using this product: use only as directed. Do not bandage tightly or use with a heating pad. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. A temporary burning sensation may occur after use but normally disappears in several days. If severe burning sensation occurs, discontinue use immediately. If swelling or blistering of the skin occurs, stop use and seek medical attention. Do not expose treated area to heat or direct sunlight.

Indications and Usage

Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.

Dosage and Administration

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Children 12 years or younger: ask a doctor.

Description

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER. Children 12 years or younger: ask a doctor.

Section 50565-1

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

Section 51727-6

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, SD Alcohol 40 (30%), Triethanolamine, Purified Water.

Section 51945-4

Section 53414-9

If pregnant or breast feeding, ask a healthcare professional before use.

Section 55105-1

Topical analgesic

Section 55106-9

Menthol 16%

Old Label


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves minor muscle and joint pain associated with arthritis, simple backache, muscle strains, sprains, bruises.

Dosage and Administration (34068-7)

Adults and children over 12 yrs of age: apply to the affected area no more than 3 to 4 times daily

IF MEDICINE COMES IN CONTACT WITH HANDS, WASH WITH SOAP AND WATER.

Children 12 years or younger: ask a doctor.

Warnings and Precautions (34071-1)

Flammable, keep away from fire or flame. When using this product: use only as directed. Do not bandage tightly or use with a heating pad. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. A temporary burning sensation may occur after use but normally disappears in several days. If severe burning sensation occurs, discontinue use immediately. If swelling or blistering of the skin occurs, stop use and seek medical attention. Do not expose treated area to heat or direct sunlight.

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Capsaicin, Glycerin, Isopropyl Myristate, Propylene Glycol, SD Alcohol 40 (30%), Triethanolamine, Purified Water.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a healthcare professional before use.

Section 55105-1 (55105-1)

Topical analgesic

Section 55106-9 (55106-9)

Menthol 16%

Old Label


Advanced Ingredient Data


Raw Label Data

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