FDA.reportPublic FDA data

Silvera Pain Relief Patch

Manufacturer
Home Aide Diagnostics, Inc.
Effective date
2015-05-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:42:34

Label at a glance#

ProductSilvera Pain Relief Patch
Active ingredientCAPSAICIN, LIDOCAINE, MENTHOL
Label structure10 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

OTCbox.jpgOTCbox.jpg

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

  • Capsaicin 0.0375% - Topical Analgesic
  • Menthol 5% - External Analgestic
  • Lidocaine 1% - Topical Analgesic

INDICATIONS & USAGE SECTION

USES

  • For relief of muscle aches and pains as well as:
  • Arthritis
  • Backaches
  • Strains
  • Sprains

WARNINGS SECTION

WARNINGS

  • Do not get into eyes or on mucous membranes
  • Do not apply to wounds, damaged or irritated skin
  • Do not bandage or cover with any type of wrap except clothing
  • Do not use with a heating pad or apply external heat
  • Do not use in large quantities, particularly over raw surfaces or blistered areas
  • This product may cause allergic reaction in some individuals

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF

  • Condition worsens
  • Severe skin irritation occurs
  • Pain persists for more than seven days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

  • If swallowed, get medical help or contact a poison control center right away

OTC - PREGNANCY OR BREAST FEEDING SECTION

IF PREGNANT OR BREAST-FEEDING

  • Ask a healthcare professional before use

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • Store below 25 oC (77 oF). Avoid direct sunlight
  • Clean and dry affected area
  • Remove patch from backing and apply to affected area
  • Use only one patch at a time and maximum of four patches daily
  • Leave patch on affeted area for up to 8-hours
  • Do not use patch for longer than 5 consecutive days unless directed by a physician
  • Children under 12 years of age should consult a physician prior to use

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS

  • Water
  • Pvpk-90
  • tartaric acid
  • NP-700
  • Aluminium hydroxide
  • EDTA2Na
  • Titanium dioxide
  • Glycerin
  • Pvpp
  • Alcohol borneol
  • Camphor

OTC - PURPOSE SECTION

  • FOR EXTERNAL USE ONLY
  • Use only as directed

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1608258capsaicin 0.0375 % / lidocaine 1 % / menthol 5 % Medicated PatchPSN1
1608258capsaicin 0.000375 MG/MG / lidocaine 0.01 MG/MG / menthol 0.05 MG/MG Medicated PatchSCD1
1608258capsaicin 0.0375 % / lidocaine 1 % / menthol 5 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130693790037204GTIN-13: 0693790037204
EAN-13: 0693790037204
GTIN-12: 693790037204
UPC-A: 693790037204
GTIN storage (14 digits): 00693790037204		OTCbox.jpg

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
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
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
69379-037-202020-01-31C16284748780-19d75b9cf-ee3d-f424-e053-dadaa90a57ceSilvera External Pain Relief Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69379-037-20Silvera Pain Relief Patch3 in 1 PACKAGEPATCH31
69379-037-20Silvera Pain Relief Patch5 in 1 BOXPATCH51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69379-037SILVERA PAIN RELIEF PATCH PATCH [HOME AIDE DIAGNOSTICS, INC.]1Legacy NDC, 2 package rows20150528_17261c31-21aa-5e21-e054-00144ff88e88.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69379-037-17EA - Each69379-037d1535bf1-ff01-4c32-a2e4-5b34e052c96512015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAPSAICINACTIVE INGREDIENTS07O44R1ZM1
LIDOCAINEACTIVE INGREDIENT98PI2009871
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAPSAICINACTIVE MOIETYS07O44R1ZM1
LIDOCAINEACTIVE MOIETY98PI2009871
MENTHOLACTIVE MOIETYL7T10EIP3A1
BORNEOLINACTIVE INGREDIENTM89NIB437X1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69379-03769379-037-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMACTIB
LIDOCAINE98PI200987ACTIB
MENTHOLL7T10EIP3AACTIB
BORNEOLM89NIB437XIACT

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
17261c31-21ab-5e21-e054-00144ff88e8817261c31-21aa-5e21-e054-00144ff88e882015-05-28WarningsExact identifier
spl id: 17261c31-21ab-5e21-e054-00144ff88e88
spl set id: 17261c31-21aa-5e21-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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