LIDOCAINE MAXIMUM STRENGTH- lidocaine patch 
TDS Pharm Co. Ltd

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.

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Maximum Strength Lidocaine Patch

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves minor pain

Warnings

For external use only

Do Not Use

  • more than 1 patch on your body at a time or on cut, irritated or swollen skin
  • on puncture wounds
  • for more than one week without consulting a doctor

When Using This Product

  • use only as directed. Read and follow all directions and warnings on this label.
  • do not allow contact with the eyes
  • do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • do not use at the same time as other topical analgesics
  • dispose of used patch in manner that always keeps product away from children or 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
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • 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

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children over 12 years:

  • clean and dry affected area
  • remove the transparent release liner (clear plastic backing) before application of patch to the skin
  • apply immediately after removal from the protective envelope
  • use 1 patch for up to 12 hours

children 12 years or younger: ask a doctor

Inactive Ingredients

aluminum glycinate, carboxymethylcellulose sodium, EDTA disodium, gelatin, concentrate glycerin, kaolin, propylene glycol, polysorbate 80, povidone, sodium polyacrylate, tartaric acid, titanium oxide

Questions or comments?

Call 1-877-753-3935  Monday-Friday 9AM-5PM EST

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

Package Label

Lidocaine 4%

Maximum Strength Lidocaine Patch

LIDOCAINE  MAXIMUM STRENGTH
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42912-0150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE246 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42912-0150-55 in 1 CARTON05/10/201701/01/2019
11 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34805/10/201701/01/2019
Labeler - TDS Pharm Co. Ltd (689951176)

Revised: 5/2017
 
TDS Pharm Co. Ltd