FIRSTCARE PAIN RELIEF GEL PATCH- lidocaine patch 
USpharma 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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FirstCare Pain Relief Gel Patch Lidocaine 4%

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 carton.
  • do not allow contacts 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 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 worsen
  • 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 and pets.

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

Directions

adults and children over 12 years:

children 12 years or younger: ask a doctor

Inactive ingredients

polyvinyl alcohol, non-crystalizing sorbitol solution, polyacrylic acid, glycerin, carboxymethylcellulose sodium, colloidal silicon dioxide, titanium dioxide, propylene glycol, tartaric acid, magnesium hydroxide, sodium polyacrylate, purified water

Package/Label Principal Display Panel

FIRST CARE TM 

***MADE IN USA***

LASTS UP TO 12 HOURS

MAXIMUM STRENGTH**

PAIN RELIEF GEL PATCH

FOR BACK, SHOULDER, NECK & JOINTS


Lidocaine 4%

Targets Muscle and Nerve Pain

Odor & Paraben Free


3-15/16” x 5-1/2” (10 cm x 14 cm)

NDC 71594-602-05

5 PATCHES

Individually sealed in child resistant packages

Carton Image

FIRSTCARE PAIN RELIEF GEL PATCH 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71594-602
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE246 mg
Inactive Ingredients
Ingredient NameStrength
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
SORBITOL (UNII: 506T60A25R)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
GLYCERIN (UNII: PDC6A3C0OX)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
TARTARIC ACID (UNII: W4888I119H)  
MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71594-602-055 in 1 CARTON10/25/2019
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 finalpart34810/25/2019
Labeler - USpharma Ltd (080664601)
Registrant - USpharma Ltd (080664601)
Establishment
NameAddressID/FEIBusiness Operations
USpharma Ltd080664601manufacture(71594-602) , pack(71594-602)

Revised: 10/2019
Document Id: 95c3738d-8c05-37c4-e053-2a95a90aa155
Set id: 3da9d94d-dd69-4125-b278-ee551dae7a55
Version: 1
Effective Time: 20191025
 
USpharma Ltd