FDA Label for Cvs Health Xl Lidocaine Pain Relief

View Indications, Usage & Precautions

Cvs Health Xl Lidocaine Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Natural Essentials, Inc.. 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 Ingredient



Lidocaine 4%


Purpose



Topical Anesthetic


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 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 product that can produce serious adverse effects if a child or pet chews or ingests this patch.

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

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



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


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 exposed portion of patch is positioned, carefully remove remaining backing to completely 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 patch not sticking
  • avoid strenuous exercise while wearing patch, this will result in patch not sticking.
  • use 1 patch for up to 12 hours

Other



Children 12 years or younger: ask a doctor


Other Information



Store at room temperature - do not exceed 86° Fahrenheit, 30° Celsius.


Inactive Ingredients



Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, Povidone, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.


Principal Display Panel – Box Label



CVS
Health

Compare to the active ingredient in
Aspercreme® Lidocaine Patch XL*

MAXIMUM STRENGTH

Lidocaine Pain
Relief Patch

XL

LIDOCAINE 4%

Topical anesthetic

Odor Free

Principal Display Panel – Patch Label



CVS
Health

Compare to the active ingredient in
Aspercreme® Lidocaine Patch XL*

MAXIMUM STRENGTH

Lidocaine Pain
Relief Patch

XL

LIDOCAINE 4%

Topical anesthetic

Odor Free

* Please review the disclaimer below.