Walgreen Cool N Heat Cream With Lidocaine

Walgreen Cool N Heat Cream With Lidocaine
SPL v4
SPL
SPL Set ID ce1b21d6-7aa6-2b18-e053-2995a90a4c91
Route
TOPICAL
Published
Effective Date 2024-09-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (1 g)
Inactive Ingredients
Water Polysorbate 80 Glycerin Benzyl Alcohol Tocopherol Isopropyl Palmitate Trolamine Hydrogenated Soybean Lecithin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-03-01

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, or for more than one week without consulting a doctor.

Indications and Usage

Temporarily relieves minor pain

Dosage and Administration
  • Adults and children over 12 years of age: Apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24 hr period.
  • Before and after applying wash hands with soap and water
  • Children under 12 years must ask a doctor

Description

Lidocaine HCL 4% Menthol 1%

Section 50565-1

Keep out of reach of children and pets

Section 50566-9

Stop using 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 few days
  • you experience signs of skin injury such as pain, swelling, or blistering where the product was applied

Section 50567-7
  • Use as directed. read and follow all directions and warnings
  • rare cases of serious burns have been reported with products of this type
  • do not bandage or apply local heat to the area of use with a medicated patch
  • avoiding contact with eyes and mucus membrane
  • a transient burning sensation may occur upon application but generally disappears in several days
Section 51727-6

Benzyl alcohol, carbomer, glycerin, hydrogenated lecithin, isopropyl palmitate, polysorbate 80, triethanolamine, Vitamin E, water

Section 51945-4

Section 53413-1

Questions? 1-800-925-4733

Section 55105-1

Topical anesthetic

Topical anagesic

Section 55106-9

Lidocaine HCL 4%

Menthol 1%


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves minor pain

Dosage and Administration (34068-7)
  • Adults and children over 12 years of age: Apply a thin layer to the affected area every 6 to 8 hours, not exceeding 3 applications in a 24 hr period.
  • Before and after applying wash hands with soap and water
  • Children under 12 years must 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, or for more than one week without consulting a doctor.

Section 50565-1 (50565-1)

Keep out of reach of children and pets

Section 50566-9 (50566-9)

Stop using 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 few days
  • you experience signs of skin injury such as pain, swelling, or blistering where the product was applied

Section 50567-7 (50567-7)
  • Use as directed. read and follow all directions and warnings
  • rare cases of serious burns have been reported with products of this type
  • do not bandage or apply local heat to the area of use with a medicated patch
  • avoiding contact with eyes and mucus membrane
  • a transient burning sensation may occur upon application but generally disappears in several days
Section 51727-6 (51727-6)

Benzyl alcohol, carbomer, glycerin, hydrogenated lecithin, isopropyl palmitate, polysorbate 80, triethanolamine, Vitamin E, water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-925-4733

Section 55105-1 (55105-1)

Topical anesthetic

Topical anagesic

Section 55106-9 (55106-9)

Lidocaine HCL 4%

Menthol 1%


Advanced Ingredient Data


Raw Label Data

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