FIRSTCARE PAIN RELIEF GEL PATCH- lidocaine patch

FirstCare Pain Relief Gel Patch by

Drug Labeling and Warnings

FirstCare Pain Relief Gel Patch by is a Otc medication manufactured, distributed, or labeled by USpharma Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

• clean and dry affected area
• remove film from patch
• carefully apply patch to affected area
• use 1 patch for up to 12 hours

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

INGREDIENTS AND APPEARANCE

FIRSTCARE PAIN RELIEF GEL PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71594-602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	246 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71594-602-05	5 in 1 CARTON	10/25/2019
1		1 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	10/25/2019

Labeler - USpharma Ltd (080664601)

Registrant - USpharma Ltd (080664601)

Establishment
Name	Address	ID/FEI	Business Operations
USpharma Ltd		080664601	manufacture(71594-602) , pack(71594-602)