FDA Label for Walgreens Cool N Heat
View Indications, Usage & Precautions
Walgreens Cool N Heat Product Label
The following document was submitted to the FDA by the labeler of this product Walgreens. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Lidocaine HCL 4%
Menthol 1%
Otc - Purpose
Topical anesthetic
Topical anagesic
Indications & Usage
Temporarily relieves minor pain
Dosage & 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
Warnings
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.
Inactive Ingredient
Benzyl alcohol, carbomer, glycerin, hydrogenated lecithin, isopropyl palmitate, polysorbate 80, triethanolamine, Vitamin E, water
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets
Otc - Stop Use
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
Otc - Questions
Questions? 1-800-925-4733
Otc - When Using
- 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
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