FDA.reportPublic FDA data

Blister Defense Patch

Manufacturer
ASO LLC
Effective date
2024-09-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:28:11

Label at a glance#

ProductCare Science
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

For the temporary relief of pain

Dosage and administration

Adults and children 12 years and over: clean and dry affected area peel film from patch and plastic liner and apply to the skin apply 1 patch at a time to affected area, not more than 3 to 4 times daily wash hands after applying patch remove patch from the skin after at most 8 hours application Children under 12 years of age: do not use, consult a physician before use.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • large quantities
  • on raw surfaces, blistered areas, wounds or damaged skin
  • if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • do not use other topical products
  • do not allow contact with eyes or mucous membranes
  • apply only to clean, dry, and untreated skin
  • use only as directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur
  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If put in mouth, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and over: clean and dry affected area
  • peel film from patch and plastic liner and apply to the skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • wash hands after applying patch
  • remove patch from the skin after at most 8 hours application
  • Children under 12 years of age: do not use, consult a physician before use.

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature
  • keep away from excessive heat
  • do not exceed 100 oF (38 oC)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylic adhesive, polyester fabric

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARE SCIENCE

4% LIDOCAINE PAIN RELIEF

BLISTER DEFENSE PATCH

DESIGNED FOR TOES AND HEELS

LASTS UP TO 8 HOURS

Maximum OTC Strength

  • For temporary relief of pain associated with pressure and friction
  • Lidocaine in adhesive temporarily numbs pain

Flexible Fabric

  • Covers and Protects Skin
  • Durable, Breathable
  • Thin and Flexible Fabric Easily conforms to Skin

Product LabelProduct Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51142-100-40Care Science5 in 1 BOXPATCH51
51142-100-40Care Science3.374 mg in 1 CELLO PACKPATCH3.3741

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51142-100CARE SCIENCE (LIDOCAINE) PATCH [ASO LLC]1Current NDC, 2 package rows20241024_22cbb664-b659-3beb-e063-6394a90a9dab.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51142-10051142-100-40
65604-100

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ETHYLENE-VINYL ACETATE COPOLYMER (15% VINYL ACETATE)V9BQI51YULIACT

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
Care ScienceLIDOCAINEASO LLC22cbb664-b659-3beb-e063-6394a90a9dab2024-09-23WarningsExact identifier
ndc (package): 51142-100-40
ndc (product): 51142-100
ndc11 (package): 51142010040
spl id: 22cbb674-78d4-64ce-e063-6394a90a11dd
spl set id: 22cbb664-b659-3beb-e063-6394a90a9dab

Reported adverse events (FAERS/openFDA)#

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