Aspercreme Patch
FDA Label NDC 62168-0585

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lead Chemical Co., Ltd. for the product Aspercreme (NDC 62168-0585). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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Label

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