NDC Code(s) : 62168-0584-4, 62168-0584-5, 62168-0584-6
Packager : Lead Chemical Co. Ltd.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

AspercremeLidocaine PATCH
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:62168-0584
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE(UNII: 98PI200987)
(LIDOCAINE - UNII:98PI200987) 		LIDOCAINE246 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
1NDC:62168-0584-4400 in 1 CARTON 17/05/2021
11 in 1 POUCH Type 0: Not a Combination Product
2NDC:62168-0584-5400 in 1 CARTON 02/02/2022
21 in 1 POUCH Type 0: Not a Combination Product
3NDC:62168-0584-6400 in 1 CARTON 15/07/2023
31 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 Drug 505G(a)(3) 02/16/2016

LABELER - Lead Chemical Co. Ltd.(693727091)

PRINCIPAL DISPLAY PANEL

MAX STRENGTH

Aspercreme®with 4% LIDOCAINE
PAIN RELIEF PATCH

NUMBS AWAY PAINFAST ACTING
TARGETS NERVES
FLEXIBLE FABRIC
#1 LIDOCAINE BRAND*

PATCH

FRAGRANCE-FREE
Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)
Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics.


Dist. by Chattem, Inc., a Sanofi Company
P.O. Box 2219, Chattanooga, TN
37409-0219 USA
©2022
www.aspercreme.com     Made in Japan

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Label

PRINCIPAL DISPLAY PANEL

MAX STRENGTH

Aspercreme®with 4% LIDOCAINE
PAIN RELIEF PATCH

NUMBS AWAY PAINFAST ACTING
TARGETS NERVES
FLEXIBLE FABRIC
#1 LIDOCAINE BRAND*

PATCH

FRAGRANCE-FREE
Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)
Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics


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

image-02

Label