FDA.reportPublic FDA data

SCADEXE PATCH

Manufacturer
Patchwerx Labs, Inc.
Effective date
2015-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:42:30

Label at a glance#

ProductSCADEXE
Active ingredientLIDOCAINE HYDROCHLORIDE, PETROLATUM, ALLANTOIN
Label structure12 sections

Label contents#

Full prescribing information#

Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Allantoin 2.00 %

Lidocaine 4.00 %

Petrolatum 30.00 %

ASK DOCTOR SECTION

OTC - ASK DOCTOR SECTION

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

DO NOT USE SECTION

OTC - DO NOT USE SECTION

- on deep or puncture wounds, animal bites, serious burns

- in large quantities, particularly over raw surfaces or blistered areas

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If pregnant or breastfeeding, contact physician prior to use

PREGNANCY OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, contact physician prior to use

PURPOSE

OTC - PURPOSE SECTION

- Temporarily protects minor cuts , scrapes and burns

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

QUESTIONS

OTC - QUESTIONS SECTION

For questions or comments please call 800-317-2910

STOP USE SECTION

OTC - STOP USE SECTION

Stop use if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

WHEN USING SECTION

OTC - WHEN USING SECTION

How to apply

- clean and dry affected area

- remove mesh from backing and apply to affected area

- use only one mesh at a time, and maximum of four mesh / day

- leave mesh on affected area for up to 8 hours

- children under 12 should consult

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

scadexe_large_low_resscadexe_large_low_res

Warnings

WARNINGS SECTION

Stop use if condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days.

Do not use if pregnant.

Keep away from Children

Inactive Ingredients These highlights do not include all the information needed to use

INACTIVE INGREDIENT SECTION

ONION

ALPHA-TOCOPHEROL

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
69329-040-302020-01-31C16284748780-19d75b9d0-9e20-f424-e053-dadaa90a57ceSCADEXE PATCH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69329-040-30SCADEXE30 in 1 BOXPATCH301
69329-040-30SCADEXE10 g in 1 PATCHPATCH101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69329-040SCADEXE (ALLANTOIN, LIDOCAINE, PETROLATUM) PATCH [PATCHWERX LABS, INC.]1Legacy NDC, 2 package rows20150507_13cfbd7c-759b-73ca-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ALLANTOINACTIVE INGREDIENT344S277G0Z1
LIDOCAINE HYDROCHLORIDEACTIVE INGREDIENTV13007Z41A1
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
ALLANTOINACTIVE MOIETY344S277G0Z1
LIDOCAINEACTIVE MOIETY98PI2009871
PETROLATUMACTIVE MOIETY4T6H12BN9U1
ALPHA-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ11
ONIONINACTIVE INGREDIENT492225Q21H1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69329-04069329-040-30

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
LIDOCAINE HYDROCHLORIDEV13007Z41AACTIR
PETROLATUM4T6H12BN9UACTIB
ONION492225Q21HIACT
ALLANTOIN344S277G0ZACTIB
ALPHA-TOCOPHEROLH4N855PNZ1IACT

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.-TOCOPHEROLH4N855PNZ1INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.64 mgExact 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.-TOCOPHEROLH4N855PNZ1SOLUTION / ORAL1.05 mg/1mlExact 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.-TOCOPHEROLH4N855PNZ1TABLET, FILM COATED / ORAL246 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, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
10 equally ranked IID candidates
ALPHA-TOCOPHEROL.ALPHA.-TOCOPHEROLH4N855PNZ1TABLET / ORAL2 mgExact 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.-TOCOPHEROLH4N855PNZ1CAPSULE / ORAL16 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
13cfbd7c-759c-73ca-e054-00144ff8d46c13cfbd7c-759b-73ca-e054-00144ff8d46c2015-04-15WarningsExact identifier
spl id: 13cfbd7c-759c-73ca-e054-00144ff8d46c
spl set id: 13cfbd7c-759b-73ca-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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