NDC Code(s) : 42912-0150-5
Packager : TDS Pharm Co. Ltd

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Lidocaine Lidocaine PATCH
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42912-0150
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)
CARBOXYMETHYLCELLULOSE SODIUM(UNII: K679OBS311)
EDETATE DISODIUM(UNII: 7FLD91C86K)
GELATIN(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
KAOLIN(UNII: 24H4NWX5CO)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
POVIDONE(UNII: FZ989GH94E)
SODIUM ACRYLATE(UNII: 7C98FKB43H)
TARTARIC ACID(UNII: W4888I119H)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42912-0150-55 in 1 CARTON 05/10/2017
11 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 05/10/2017

PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Maximum Strength Aspercreme® Lidocaine Patch

Maximum Strength

Lidocaine Patch

Lidocaine 4%

Topical anesthetic

  • fast acting
  • numbs away pain
  • desensitizes aggravted nerves
  • no irritation and no burning
  • odor-free

†This product is not manufactured or distributed by Chattem, Inc., distributor of Maximum Strength Aspercreme® Lidocaine Patch.

Manufactured by:

TDS Pharm Co., Ltd.

12-13 Hanbul-ro 69beon-gil, Eumseong-eup,

Eumseong, Chungbuk 27698 Republic of Korea

www.tdspharm.com

PRINCIPAL DISPLAY PANEL

Lidocaine 4%Maximum Strength Lidocaine Patch