FDA.reportPublic FDA data

RelieveIt Footspray

Manufacturer
Cosmetic Specialty labs, Inc.
Effective date
2020-03-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:03:57

Label at a glance#

ProductRelieveIt Footspray Topical Analgesic
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

For temporary relief of minor aches and pains of muscles, joints and feet.

Dosage and administration

• Spray balls of feet. arches, heels, toes and legs on bare skin before starting your day or activity: 6 - 8 sprays each foot· Apply generously when wearing stockings; 8+ sprays each foot • Let dry completely • Apply again as needed for extended relief Children under 2: consult a doctor before use • Spray balls of feet. arches, heels, toes and legs on bare skin before starting your day or activity: 6 - 8 sprays ea...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 8.0%

Purpose

OTC - PURPOSE SECTION

External analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles, joints and feet.

Warnings

WARNINGS SECTION

for external use only

When using this product: use only as directed• avoid contact with eyes or mucous membrane• do not apply to open wounds, damaged or very sensitive skin • Do not use if you are allergic to any of this product's Active or Inactive ingredients

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

• Spray balls of feet. arches, heels, toes and legs on bare skin before starting your day or activity:

6 - 8 sprays each foot· Apply generously when wearing stockings; 8+ sprays each foot

• Let dry completely • Apply again as needed for extended relief

Children under 2: consult a doctor before use

Directions

RECENT MAJOR CHANGES SECTION

• Spray balls of feet. arches, heels, toes and legs on bare skin before starting your day or activity:

6 - 8 sprays each foot· Apply generously when wearing stockings; 8+ sprays each foot

• Let dry completely • Apply again as needed for extended relief

Children under 2: consult a doctor before use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Arnica Montona, Cyclomethicone, Ethyl Alcohol. Ethoxydiglycol. Eucalyptus Oil. Horpogophytum. lsopropyl Palmitate, Lemon Oil, Lemongrass Oil, Pinus Resin, Propylene Glycol, Peppermint Oil, Teo Tree Oil, Wintergreen Oil

SPL UNCLASSIFIED SECTION

Manufactured for: SprainGo, LLC

3802 Spectrum Blvd, Suite 112E

Tampa, FL 33612

Made in the USA

Other Information

OTHER SAFETY INFORMATION

• Do not use if the package seal is broken• Store at 68-77°F (20 -25°)

• Keep this package. It contains important information on directions for use

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

refillrefilllabellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-956-012024-01-30C16284748780-11030e365-0691-111a-e063-dadaa90a10e2RelieveIt Footspray
58133-956-022024-01-30C16284748780-11030e365-0691-111a-e063-dadaa90a10e2RelieveIt Footspray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-956-01RelieveIt FootsprayTopical Analgesic30 mL in 1 CARTONLIQUID301
58133-956-02RelieveIt FootsprayTopical Analgesic30 mL in 1 CARTONLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-956RELIEVEIT FOOTSPRAY TOPICAL ANALGESIC (MENTHOL 8%) LIQUID [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 2 package rows20200314_a0c0cbac-6adf-d85d-e053-2995a90a5da5.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-95658133-956-01, 58133-956-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YIACT
CYCLOMETHICONENMQ347994ZIACT
BIS-ETHOXYDIGLYCOL CYCLOHEXANE 1,4-DICARBOXYLATER6MU0U9L45IACT
HARPAGOPHYTUM PROCUMBENS ROOT1OYM338E89IACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
LEMON OILI9GRO824LLIACT
EAST INDIAN LEMONGRASS OILUP0M8M3VZWIACT
PEPPERMINT OILAV092KU4JHIACT
TEA TREE OILVIF565UC2GIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
1-(3-AMINO-4-HYDROXYPHENYL)-2-((2-(4-METHOXYPHENYL)-1-METHYLETHYL)AMINO)ETHANOLGJY78AX70QIACT
PINUS RESINOSA WHOLEAS8B4M6X9NIACT
MENTHOLL7T10EIP3AACTIB
EUCALYPTUS OIL2R04ONI662IACT
PROPYLENE GLYCOL 1-ALLYL ETHERQRB8092KPKIACT

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
a0c0b3e2-d72e-81bf-e053-2995a90ad9a0a0c0cbac-6adf-d85d-e053-2995a90a5da52020-03-13WarningsExact identifier
spl id: a0c0b3e2-d72e-81bf-e053-2995a90ad9a0
spl set id: a0c0cbac-6adf-d85d-e053-2995a90a5da5

Reported adverse events (FAERS/openFDA)#

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