FDA.reportPublic FDA data

Elite Pain Relief Patch

Manufacturer
Meds Direct Rx, Inc. | Foshan Aqua Gel Biotech Co. Ltd
Effective date
2015-11-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 22:44:07

Label at a glance#

ProductElite PAIN RELIEF
Active ingredientALLANTOIN, LIDOCAINE, PETROLATUM
Label structure10 sections

Indications and uses

Temporarily protects minor cuts, scrapes and burns Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations

Dosage and administration

•Clean and dry affected area •Remove mesh from backing and apply to affected area •Use only one mesh at a time, and maximum of 4 mesh/day • Leave mesh on affected area for up to 8 hours •Do not use mesh for longer than 5 consecutive days •Children under 12 should consult physician prior to use

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Allantoin  2.00%

Lidocaine  4.00%

Petrolatum  30.00%

OTC - PURPOSE SECTION

Skin Protectant

Topical Anesthetic

SkinProtectant

USES:

INDICATIONS & USAGE SECTION

Temporarily protects minor cuts, scrapes and burns

Temporary relief of pain associated with minor cuts, scrapes and minor skin irritations

WARNINGS:

WARNINGS SECTION

•For external use only.

•Avoid contact with eyes.

•Stop use and ask a doctor if condition worsens, or symptoms last more than 7 days, or clear up and occur again within a few days.

•Do not use on deep or puncture wounds, animal bites, or serious burns.

•If pregnant or breast feeding, contact physician prior to use.

• Do not use in large quantities, particularly over raw surfaces or blistered areas.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

•Clean and dry affected area

•Remove mesh from backing and apply to affected area

•Use only one mesh at a time, and maximum of 4 mesh/day

• Leave mesh on affected area for up to 8 hours

•Do not use mesh for longer than 5 consecutive days

•Children under 12 should consult physician prior to use

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Vitamin E, Onion Extract, Dihydroxyaluminum Aminoacetate, Disodium Edetate, Gelatin, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Polyacrylate, D-Sorbitol, Tartaric Acid, Urea, Sodium Carboxymethylcellulose

SPL UNCLASSIFIED SECTION

Store below 25° degrees. Avoid direct sunlight.

SPL UNCLASSIFIED SECTION

Manufactured For:

Meds Direct Rx, Inc

882 Third Avenue 1Oth Floor Suite 1000

Brooklyn, NY 11232

Questions or Comments call 855-480-MEDS

Made in China

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EliteFrontEliteFront

EliteBACKEliteBACK

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1540663allantoin 2 % / lidocaine 4 % / petrolatum 30 % Medicated PatchPSN6
1540663allantoin 0.02 MG/MG / lidocaine 0.04 MG/MG / petrolatum 0.3 MG/MG Medicated PatchSCD6
1540663allantoin 2 % / lidocaine 4 % / petrolatum 30 % Medicated PatchSY6

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
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
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
69418-004-152020-01-31C16284748780-19d75b9d0-7fe7-f424-e053-dadaa90a57ceElite Pain Relief Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69418-004-15Elite PAIN RELIEF15 g in 1 PATCHPATCH156

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69418-004ELITE PAIN RELIEF (ALLANTOIN, LIDOCAINE, PETROLATUM) PATCH [MEDS DIRECT RX, INC.]6Legacy NDC, 1 package rows20151119_26911234-231b-4867-8fa6-3458a352a774.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0Z6
LIDOCAINEACTIVE INGREDIENT98PI2009876
PETROLATUMACTIVE INGREDIENT4T6H12BN9U6
ALLANTOINACTIVE MOIETY344S277G0Z6
LIDOCAINEACTIVE MOIETY98PI2009876
PETROLATUMACTIVE MOIETY4T6H12BN9U6
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ16
ONIONINACTIVE INGREDIENT492225Q21H6

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69418-00469418-004-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
ONION492225Q21HIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
ALLANTOIN344S277G0ZACTIB
LIDOCAINE98PI200987ACTIB
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1FILM, SOLUBLE / BUCCAL0.07 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1SYSTEM / TOPICAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1OINTMENT / TOPICALNAExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, CHEWABLE / ORAL0.1 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
.ALPHA.-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact identifier — unii candidate
10 equally ranked IID candidates

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
24d86c23-6655-00dc-e054-00144ff8d46c26911234-231b-4867-8fa6-3458a352a7742015-11-18WarningsExact identifier
spl id: 24d86c23-6655-00dc-e054-00144ff8d46c
spl set id: 26911234-231b-4867-8fa6-3458a352a774

Reported adverse events (FAERS/openFDA)#

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