Assured Pain Relief

Manufacturer
Foshan Aqua Gel Biotech Co., Ltd.,
Effective date
2017-09-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:28

Label at a glance#

ProductAssured Pain Relief
Active ingredientLIDOCAINE
Label structure10 sections

Storage and handling

Other information •Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight •Protect product from excessive moisture

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Lidocaine 4%

OTC - PURPOSE SECTION

Purpose

Topical analgesic

INDICATIONS & USAGE SECTION

Uses temporarily releives minor pain

WARNINGS SECTION

Warnings for external use only.

Do not use

•more than one patch on your body at a time or on cut •on wounds or damaged skin •with a heating pad

When using this product

•avoid contact with eyes, mucous membranes or rashes •use only as directed •do not bandage tightly

•do not use at the same time as other topical analgesics •dispose of used patch in a manner that always keeps products away from children and pets

Stop use and ask a doctor if

•you experience signs of skin injury, such as pain, swelling or blistering where product was applied •symptoms persist for more than 7

days or clear up and occur again within a few days •condition worsens •redness is present •irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. On case of accidental ingestion, get medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Pregnancy.breast-feeding warning. If pregant or breast-feeding, ask a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 years of age and over:

•Clean and dry affected area •Remove film from patch and apply to the skin (see package for instructions)

•Apply to affected area not more than 3 to 4 times daily •Remove patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a physician

STORAGE AND HANDLING SECTION

Other information

•Store at room temperature 58° - 86° F (15° - 30° C). Acoid storing product in direct sunlight •Protect product from excessive moisture

INACTIVE INGREDIENT SECTION

Inactive ingredients DIHYDROXYALUMINUM AMINOACETATE, GLYCERIN, KAOLIN, METHYLPARABEN, PROPYLPARABEN, PROPYLENE GLYCOL,

PVP, POLYACRYLIC ACID, POLYSORBATE 80, SODIUM POLYACRYLATE, TITANIUM DIOXIDE, TARTARIC ACID, WATER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69159-101-012020-01-31C16284748780-19d75b9d1-105c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69159-100-01Assured Pain Relief15 g in 1 PATCHGEL100 g4 g in 100g2
69159-101-01Assured Pain Relief1 in 1 KITKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69159-100ASSURED PAIN RELIEF (LIDOCAINE) KIT [FOSHAN AQUA GEL BIOTECH CO., LTD.,]2Legacy NDC20170911_ecb499d7-64a9-4053-92f6-5fe2d28c87c5.zip
69159-101ASSURED PAIN RELIEF (LIDOCAINE) KIT [FOSHAN AQUA GEL BIOTECH CO., LTD.,]2Legacy NDC, 2 package rows20170911_ecb499d7-64a9-4053-92f6-5fe2d28c87c5.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69159-10169159-101-01
69159-10069159-100-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
4d8b9c76-3f7f-4e19-b58c-1be1aa9bc456ecb499d7-64a9-4053-92f6-5fe2d28c87c52017-09-10WarningsExact identifier
spl id: 4d8b9c76-3f7f-4e19-b58c-1be1aa9bc456
spl set id: ecb499d7-64a9-4053-92f6-5fe2d28c87c5

Reported adverse events (FAERS/openFDA)#

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