LIDOCAINE PAIN RELIEVING- lidocaine patch 
Unexo Life Sciences Private Limited

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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Lidocaine Pain Relieving Patch

Drug Facts

Active Ingredient

Lidocaine 4.0%

Topical anesthetic

Uses

Temporarily relieves minor pain.

Warnings

For external use only

Do not use

  • More than one patch on your body at a time
  • On cut, irritated or swollen skin
  • On puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • If pouch is damaged or opened.

When using this product

  • Use only as directed
  • Read and follow all directions and warnings on this pack
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • 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
  • 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 (1-800-222-1222) right away.

Directions

Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or Comments

Call 1-888-287-1915

Manufactured By:

UNEXO LIFE SCIENCES PVT. LTD.
B-16. Sector 4, Bawana Industrial Area,
Delhi – 110039 (INDIA)

PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label

NDC: 71391-150-01

LIDOCAINE
PAIN
RELIEVING
PATCH

LIDOCAINE 4% / Topical Anesthetic

Temporarily relieves pain
Stay-Put flexible Patch
Easy to apply & remove
No-mess, single use application
Odor-free

Lasts upto 12 hours

1 PATCH
3.93 X 5.5 IN
(10cm X 14cm)

PRINCIPAL DISPLAY PANEL - 1 Patch Pouch Label
LIDOCAINE PAIN RELIEVING 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71391-150
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Lidocaine (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) Lidocaine344 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
Glycerin (UNII: PDC6A3C0OX)  
Kaolin (UNII: 24H4NWX5CO)  
Methylparaben (UNII: A2I8C7HI9T)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
Polysorbate 80 (UNII: 6OZP39ZG8H)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
Tartaric Acid (UNII: W4888I119H)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71391-150-011 in 1 POUCH; Type 0: Not a Combination Product02/01/2022
2NDC:71391-150-055 in 1 BOX02/01/2022
2NDC:71391-150-011 in 1 POUCH; Type 0: Not a Combination Product
3NDC:71391-150-066 in 1 BOX02/01/2022
3NDC:71391-150-011 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/01/2022
Labeler - Unexo Life Sciences Private Limited (872260479)
Establishment
NameAddressID/FEIBusiness Operations
Unexo Life Sciences Private Limited872260479MANUFACTURE(71391-150)

Revised: 2/2022
Document Id: 06c4c945-3baf-4e4f-bd0b-3a6a5ff392b2
Set id: 9b916733-4b34-427c-81e6-a62c70fa51a4
Version: 1
Effective Time: 20220209
 
Unexo Life Sciences Private Limited