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NDC 71594-0600-05 FirstCare Pain Relief Gel Patch 246 mg/1 Details

FirstCare Pain Relief Gel Patch 246 mg/1

FirstCare Pain Relief Gel Patch is a TOPICAL PATCH in the HUMAN OTC DRUG category. It is labeled and distributed by USpharma Ltd. The primary component is LIDOCAINE.

MedlinePlus Drug Summary

Prescription lidocaine transdermal (Dermalid, Lidoderm, Ztildo) is used to relieve the pain of post-herpetic neuralgia (PHN; burning, stabbing pains, or aches that may last for months or years after a shingles infection). Nonprescription (over-the-counter) lidocaine (Absorbine Jr, Aspercreme, Lidocare, Salonpas, others) is also available to relieve minor pain in shoulders, arms, neck and legs in adults and children 12 years of age and older. Lidocaine is in a class of medications called local anesthetics. It works by stopping nerves from sending pain signals.

Related Packages: 71594-0600-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Lidocaine Transdermal Patch

Product Information

NDC	71594-0600
Product ID	71594-600_b17cc9ac-c19c-4cb2-e053-2a95a90af029
Associated GPIs	90850060005920
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	FirstCare Pain Relief Gel Patch
Proprietary Name Suffix	n/a
Non-Proprietary Name	Lidocaine
Product Type	HUMAN OTC DRUG
Dosage Form	PATCH
Route	TOPICAL
Active Ingredient Strength	246
Active Ingredient Units	mg/1
Substance Name	LIDOCAINE
Labeler Name	USpharma Ltd
Pharmaceutical Class	Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part348
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71594-0600-05 (71594060005)

Pricing Information	N/A
NDC Package Code	71594-600-05
Billing NDC	71594060005
Package	5 POUCH in 1 CARTON (71594-600-05) / 1 PATCH in 1 POUCH
Marketing Start Date	2020-10-12
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e6ac015b-464c-471f-bdb6-2f9658fd3163 Details

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 71594-600-05

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:71594-600
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
POLYVINYL ALCOHOL (100000 MW) (UNII: 949E52Z6MY)
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71594-600-05	5 in 1 CARTON	10/12/2020
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	10/12/2020

Labeler - USpharma Ltd (080664601)

Name	Address	ID/FEI	Business Operations
Establishment
USpharma Ltd		080664601	manufacture(71594-600) , pack(71594-600)

Revised: 10/2020

Document Id: b17cc9ac-c19c-4cb2-e053-2a95a90af029

Set id: e6ac015b-464c-471f-bdb6-2f9658fd3163

Version: 1

Effective Time: 20201012