FDA Label for Cvs Cold And Hot Pain Relief
View Indications, Usage & Precautions
Cvs Cold And Hot Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy. 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.
Active Ingredients
Lidocaine 4%
Menthol 1%
Purposes
Topical Anesthetic
Topical Analgesic
Use
For the temporary relief of pain.
Warnings
For external use only
Do Not Use
- more than 1 patch on your body at a time 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 carton.
- Do not use more than one patch in an 8 hour period. Maximum 3 patches per day.
- Rare cases of serious burns have been reported with products of this type
- Do not apply to wounds or damaged, broken, or irritated skin
- Do not allow contact with the eyes or mucous membranes
- Do not bandage tightly or apply local heat (such as heating pads) to the area of use
- Do not use at the same time as other topical analgesics
- Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug products that can produce serious adverse effects if a child or pet chews or ingests this patch
- NOTE: patches may not adhere as well to all individuals, skin types, or certain parts of the body.
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 physician before use.
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Adults/children 12 years and older
- clean and dry affected area
- remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
- carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
- once sposed portion of patch is postiioned, carefully remove remaining backing completely to apply patch to affected area
- once applied, press firmly and rub on all sides and center of patch to help adhesive adhere to skin
- do not remove patch and reapply, this will result in the patch not sticking
- avoid strenuous exercise while wearing patch, this will result in patch not sticking
- do not use more than one patch in an 8 hour period.
- Children 12 years or younger: ask a doctor.
Other Information
Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius.
Inactive Ingredients
Aluminium Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, Povidone, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.
Principal Display Panel - 3 15/16 In X 5 1/2 In Carton Label
CVS Health ®
Compare to the active ingredients in IcyHot ® Lidocaine Patch Plus Menthol*
Maximum Strength
Lidocaine concentration without a prescription †
Lidociane Pain Relief Patch
Plus Menthol
Lidocaine 4%
Menthol 1%
- Desensitizes aggravated nerves
- Easy to apply
- Fast acting
Topical Anesthetic
Topical Analgesic
Package Contains 5 Individually Wrapped Patches
5 PATCHES
3 15/16 IN X 5 1/2 IN (10 cm X 14 cm)
Pain-relieving ointment on a breathable adhesive pad
EACH PATCH IS SEALED IN A CHILD-RESISTANT POUCH FOR SAFETY
†Among over-the-counter topical analgesics
* Please review the disclaimer below.
