Aspercreme Lidocaine XL LIDOCAINE LEAD CHEMICAL CO., LTD. FDA Approved Use for the temporary relief of pain
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Substance Lidocaine
Route
TOPICAL
Applications
505G(A)(3)
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Lidocaine 4%
Inactive Ingredients
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
Strengths
4 %
Treats Conditions
Use For The Temporary Relief Of Pain

Identifiers & Packaging

Container Type BOX
All Product Codes
UNII
98PI200987
Packaging

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 image-01

Package Descriptions
  • 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 image-01

Overview

Use for the temporary relief of pain

Indications & Usage

Use for the temporary relief of pain

Dosage & Administration

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

Warnings & Precautions
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.
Purpose

Purpose Topical anesthetic

Do Not Use

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

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 & Ask a Doctor

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

Keep Out of Reach of Children

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


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