Pro Comfort 8 Hours Patch

Manufacturer
CARE LIVING DIAGNOSTICS INC
Effective date
2023-07-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:55:46

Label at a glance#

ProductPro Comfort 8 Hours Patch
Active ingredientLIDOCAINE
Label structure17 sections

Indications and uses

for the temporary relief of pain

Dosage and administration

Adults and children 12 years of age and older: Wash and dry the affected area. Peel off the backing film from one side of the patch carefully. Apply the exposed portion of the patch to the affected area. Gently press the patch with your hand to fit the affected area completely. Do not exercise vigorously during use to prevent the patch from falling off. Ues only 1 patch for a maximum of 8 hours. children under 12 ...

Label contents#

Full prescribing information#

Product Information

INDICATIONS & USAGE SECTION

patchpatch

Active Ingredient

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Purpose

Topical Anesthetic

Uses

for the temporary relief of pain

Warnings

For external use only

Do not use

  • more than 1 patch on your body at a time
  • on puncture wounds,
  • on cuts, irritated or swollen skin
  • 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 contact 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 worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness or irritation develops
  • 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 (1-800-222-1222).

Directions

Adults and children over 12 years:

  • wish and dry affected area
  • Peel off the backing fim from one side of the patch carefully
  • Apply the exposed portion of the patch to the affected area
  • Gently press the patch with your hand to fit the affected area completely
  • Do not exercise vigorously during use to prevent the patch from falling off
  • use only 1 patch for a maximum of 8 hours

children under 12 years of age: Ask a doctor before use

Other Information

store at room temperature 15°-30°C (59°-86°F).

Inactive ingredients

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water


Questions or Comments?
E-mail: info@carelivingusa.com


Child-Resistant Packaging
Manufactured for

CARE LIVING DIAGNOSTICS INC.

Www.carelivingusa.com

Made in China

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

ABUSE SECTION

for the temporary relief of 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
  • on puncture wounds,
  • on cuts, irritated or swollen skin
  • 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 contact 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 - ASK DOCTOR SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness or iritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering wherethe 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

lf swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222)

Directions

OTHER SAFETY INFORMATION

Adults and children 12 years of age and older:

  • Wash and dry the affected area.
  • Peel off the backing film from one side of the patch carefully.
  • Apply the exposed portion of the patch to the affected area.
  • Gently press the patch with your hand to fit the affected area completely.
  • Do not exercise vigorously during use to prevent the patch from falling off.
  • Ues only 1 patch for a maximum of 8 hours.

children under 12 years of age:Ask a doctor before use.

Other Information

OTHER SAFETY INFORMATION

store at room temperature 15°-30°C (59°-86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol, sodium polyacrylate, tartaric acid, poval, alcohol, water

Questions or Comments?

OTC - QUESTIONS SECTION

E-mail:info@carelivingusa.com

Dosage

DOSAGE & ADMINISTRATION SECTION

0.246 g in 1 PATCH,5 PATCH in 1 CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PATCHPATCH

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83568-4643-52024-07-30C16284748780-11e7a6dab-1acf-a2ce-e063-dadaa90aadf7019efef6-b8c0-59ec-e063-6294a90a3468

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83568-4643-1Pro Comfort 8 Hours Patch4 g in 1 PATCHPATCH42
83568-4643-5Pro Comfort 8 Hours Patch5 in 1 BOXPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83568-4643PRO COMFORT 8 HOURS PATCH (LIDOCAINE PATCH 4%) PATCH [CARE LIVING DIAGNOSTICS INC]22 package rows20230802_019efef6-b8c0-59ec-e063-6294a90a3468.zip

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
83568-464383568-4643-1, 83568-4643-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

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
019efef6-b8c1-59ec-e063-6294a90a3468019efef6-b8c0-59ec-e063-6294a90a34682023-07-29WarningsExact identifier
spl id: 019efef6-b8c1-59ec-e063-6294a90a3468
spl set id: 019efef6-b8c0-59ec-e063-6294a90a3468

Reported adverse events (FAERS/openFDA)#

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