FDA Label for Aspercreme Lidocaine Xl

View Indications, Usage & Precautions

Aspercreme Lidocaine Xl Product Label

The following document was submitted to the FDA by the labeler of this product Lead Chemical Co., Ltd.. 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



  • •on puncture wounds, cuts, irritated or swollen skin
  • •more than 1 patch on your body at a time or with other topical analgesics at the same time
  • •with a heating pad or apply local heat to the area of use

When Using This Product



  • •use only as directed
  • •do not bandage tightly
  • •avoid contact with the eyes
  • •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 or symptoms persist for more than 7 days
  • •symptoms clear up and occur again within a few days
  • •redness or irritation develops
  • •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.


Directions



adults and children 12 years of age 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
  • •use 1 patch at a time and not more than 3 to 4 times daily
  • children 12 years or younger: consult a doctor


Inactive Ingredients



aluminum glycinate, aluminum hydroxide, cellulose gum, glycerin, methyl acrylate/2-ethylhexyl acrylate copolymer, methylparaben, nonoxynol-30, polyacrylic acid, polysorbate 80, propylene glycol, silica, sodium polyacrylate, tartaric acid, titanium dioxide, urea, water


Package/Label Principal Display Panel



MAX STRENGTH

Aspercreme®
with 4% LIDOCAINE
PAIN RELIEF PATCH

NUMBS AWAY PAIN
FAST ACTING
TARGETS NERVES
FLEXIBLE FABRIC

#1 LIDOCAINE BRAND*

XL PATCH
71% LARGER

FRAGRANCE-FREE
Contains 1 Patch 4-¾” x 7-7/8” (12 cm x 20 cm)
Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics.
Than 10 cm x 14 cm Aspercreme® patches.


CHATTEM®
A SANOFI COMPANY
Dist. By Chattem, Inc., a Sanofi Company
P.O. Box 2219, Chattanooga, TN
37409-0219 USA
©2020
www.aspercreme.com     Made in Japan

Label


* Please review the disclaimer below.