Walgreens Cool N' Heat Cream + Lidocaine

Walgreens Cool N' Heat Cream + Lidocaine
SPL v2
SPL
SPL Set ID 9984138c-aff0-51ac-e053-2a95a90a7469
Route
TOPICAL
Published
Effective Date 2020-03-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Menthol (1 g)
Inactive Ingredients
.alpha.-tocopherol Acetate Trolamine Hydrogenated Soybean Lecithin Water Benzyl Alcohol Carbomer 940 Polysorbate 80 Propylene Glycol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-01-04

Description

Lidocaine HCl 4% Menthol 1%


Medication Information

Warnings and Precautions

For external use only

Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, for more than one week without consulting a doctor.

When using this product use only as directed. Read and follow all directions and warnings on this label, rare cases of serious burns have been reported with products of this type, do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated, avoid contact with eyes and mucous membranes, a transient burning sensation may occur upon application but generally disappears in several days.

Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

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

Keep out of reach of children and pets.

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

Indications and Usage

temporary relieves minor pain

Dosage and Administration

Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period.

BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

Children under 12 years: ask a doctor

Description

Lidocaine HCl 4% Menthol 1%

Section 51727-6

benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water triethanolamine, vitamin E

Section 51945-4

Section 55105-1

Topical anesthetic

Topical analgesic

Section 55106-9

Lidocaine HCl 4%

Menthol 1%


Structured Label Content

Indications and Usage (34067-9)

temporary relieves minor pain

Dosage and Administration (34068-7)

Adults and children 12 years and older: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 to 4 applications in a 24-hour period.

BEFORE AND AFTER APPLYING, WASH HANDS WITH SOAP AND WATER.

Children under 12 years: ask a doctor

Warnings and Precautions (34071-1)

For external use only

Do not use on large areas of the body or on cut, irritated or swollen skin, on puncture wounds, for more than one week without consulting a doctor.

When using this product use only as directed. Read and follow all directions and warnings on this label, rare cases of serious burns have been reported with products of this type, do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated, avoid contact with eyes and mucous membranes, a transient burning sensation may occur upon application but generally disappears in several days.

Stop use and ask a doctor if condition worsens, redness is present, irritation develops, symptoms persist for more than 7 days or clear up and occur again within a few days, you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

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

Keep out of reach of children and pets.

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

Section 51727-6 (51727-6)

benzyl alcohol, carbomer, hydrogenated lecithin, polysorbate 80, propylene glycol, purified water triethanolamine, vitamin E

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical anesthetic

Topical analgesic

Section 55106-9 (55106-9)

Lidocaine HCl 4%

Menthol 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)