Label: ASPERCREME LIDOCAINE XL- lidocaine patch
- NDC Code(s): 62168-0585-1, 62168-0585-2
- Packager: Lead Chemical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated June 23, 2021
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- Active ingredient
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
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
Package/Label Principal Display Panel
with 4% LIDOCAINE
PAIN RELIEF PATCH
NUMBS AWAY PAIN
#1 LIDOCAINE BRAND*
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.
A SANOFI COMPANY
Dist. By Chattem, Inc., a Sanofi Company
P.O. Box 2219, Chattanooga, TN
www.aspercreme.com Made in Japan
INGREDIENTS AND APPEARANCE
ASPERCREME LIDOCAINE XL
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-0585 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 411.4 mg Inactive Ingredients Ingredient Name Strength DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) NONOXYNOL-30 (UNII: JJX07DG188) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TARTARIC ACID (UNII: W4888I119H) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) UREA (UNII: 8W8T17847W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62168-0585-1 240 in 1 CARTON 10/15/2017 03/31/2023 1 1 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:62168-0585-2 240 in 1 CARTON 05/28/2021 2 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 10/15/2017 Labeler - Lead Chemical Co., Ltd. (693727091) Establishment Name Address ID/FEI Business Operations Lead Chemical Co., Ltd. 718216992 ANALYSIS(62168-0585) , MANUFACTURE(62168-0585)