FDA.reportPublic FDA data

FirstCare Pain Relief Gel Patch

Manufacturer
USpharma Ltd
Effective date
2021-06-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:42:47

Label at a glance#

ProductFirstCare Pain Relief Gel Patch
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

Temporarily relieves minor pain

Dosage and administration

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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

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 71594-601-05

5 PATCHES

Individually sealed in child resistant packages

Carton LabelCarton Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71594-601-05EA - Each71594-6015bc4a601-05ea-481d-a779-b9399fa3e03d12021-08-05

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71594-60171594-601-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYVINYL ALCOHOL (100000 MW)949E52Z6MYIACT
SORBITOL506T60A25RIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TARTARIC ACIDW4888I119HIACT
MAGNESIUM HYDROXIDENBZ3QY004SIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0ec69c80-9f09-7a9e-e063-6394a90a2db8a35e133b-30cc-471a-affe-80467aa707ef2024-01-12WarningsExact identifier
spl set id: a35e133b-30cc-471a-affe-80467aa707ef

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.