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.