FDA.reportPublic FDA data

SOLE AMIE 4% Lidocaine FOOT SPRAY

Manufacturer
Sole Amie | Inspec Solutions
Effective date
2026-03-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:50:21

Label at a glance#

ProductShoe Pain Relief
Active ingredientLIDOCAINE HCL
Label structure7 sections

Indications and uses

For temporary relief of foot pain associated with fatigue, minor cuts, minor scrapes, minor skin irritations

Dosage and administration

For adult use: apply a thin layer to your feet before wearing shoes, and as needed. Do not use more than 3 to 4 times daily

Label contents#

Full prescribing information#

Active Ingredeints                Purpose

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCI 4%                 Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of foot pain associated with fatigue, minor cuts, minor scrapes, minor skin irritations

Directions

DOSAGE & ADMINISTRATION SECTION

For adult use: apply a thin layer to your feet before wearing shoes, and as needed. Do not use more than 3 to 4 times daily

Warning For external use only 

WARNINGS SECTION

Flamable:keep away fom fire or flame

When using this product: avoid spraying in eyes; contents under pressure; do not puncture or incinerate; do not store  at temperature above 120F

Stop use and ask doctor if: condition worsens, or if symptoms persist for more than 7 days, or clear up and reossu again withing few days

Keep out of reach children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help, or contact  a Poison Control center right away

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer
Alcohol Denat
Aloe Barbadensis Leaf
Benzoic Acid
C12-15 Alkyl Benzoate
Chamomilla Recutita (Matricaria) Flower Extract
Dimethylpolysiloxane
Dimethyl Siloxane reaction with silica
Disodium EDTA
Ethylhexylglycerin
Glycerin
Glycerides, C14-18, mono and di
Glycerol
Lavandula Angustifolia (Lavender) Oil
Methylparaben
Octamethylcycloetrasiloxane
1,2- Propanediol, 3-(4-chiorophenoxy)
Phenoxyethanol
Polyethylene Glycol
Propylene Glycol
Polyethylene Glycol Stearate
Tocopheryl Acetate
Triethanolamine
Water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045432lidocaine HCl 4 % Topical SprayPSN2
1045432lidocaine hydrochloride 40 MG/ML Topical SpraySCD2
1045432lidocaine HCl 4 % Topical SpraySY2
1045432lidocaine HCl 4 % Topical Spray GelSY2

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
QR code linkQR Codeqrco.de/bdKEG3Label.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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
87288-001-01Shoe Pain Relief28 g in 1 CANSPRAY282

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87288-00187288-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
ALCOHOL3K9958V90MIACT
ALOEV5VD430YW9IACT
BENZOIC ACID8SKN0B0MIMIACT
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
EDETATE DISODIUM7FLD91C86KIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCERINPDC6A3C0OXIACT
HYDROGENATED C12-18 MONO- AND DIGLYCERIDES82TZ9D9546IACT
GLYCEROL FORMAL3L7GR2604EIACT
LAVANDULA ANGUSTIFOLIA (LAVENDER) OILZBP1YXW0H8IACT
METHYLPARABENA2I8C7HI9TIACT
CYCLOMETHICONE 4CZ227117JEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYETHYLENE GLYCOL 1100Y4QO2MSY3XIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-8 STEARATE2P9L47VI5EIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
TRIETHANOLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
LIDOCAINE HCLV13007Z41AACTIR

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
Shoe Pain ReliefLIDOCAINE HCI 4%Sole Amie0f2ccd5f-b9f4-40fc-b82f-173b0f19bf402026-03-16WarningsExact identifier
ndc (package): 87288-001-01
ndc (product): 87288-001
ndc11 (package): 87288000101
spl id: 4d25bc71-f2c3-bcdf-e063-6394a90a179f
spl set id: 0f2ccd5f-b9f4-40fc-b82f-173b0f19bf40

Reported adverse events (FAERS/openFDA)#

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