FDA.reportPublic FDA data

Real Time Pain Relief Foot Cream

Manufacturer
Real Time Products Inc.
Effective date
2024-07-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:57

Label at a glance#

ProductReal Time Pain Relief Foot
Active ingredientMENTHOL
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscle and joints, associated with arthritis, strains, bruises, and sprains.

Dosage and administration

Adults and Children over 2 years: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.50%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscle and joints, associated with arthritis, strains, bruises, and sprains.

Warnings:

WARNINGS SECTION

Do notapply to wounds or damaged skin or bandage tightly.

For external use only.

When using this product:

OTC - WHEN USING SECTION

Avoid contact with eyes.

Stop use and ask doctor if:

OTC - STOP USE SECTION

Condition worsens 

  • Symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and Children over 2 years: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Anthemis Nobilis (Roamn Chamomile) Oil, Aqua (Deionized Water), Ascorbic Acid (Vitamin-C), Calendula Officinalis Extract, Caprylyl Glycol, Centaurea Cyanus (Cornflower) Extract, Ceresin Wax, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Mantricaria (Chamomile) Extract, Coriandrum Sativum (Coriander) Oil, Emu Oil, Eucalyptus Globulus Oil, Glycerin, Hydrogenated Vegetable Oil, Hypericum Perforatum (St.John's Wort), Lactic Acid, Lanolin, Melaleuca Alternifolia (Tea Tree) Oil, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-80, Retinyl Palmitate (Vitamin A), Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sodium Borate, SorbitanSesquioleate, Stearyl Alcohol, Tilia Cordata (Linden) Bark Extract, Tocopheryl Acetate (Vitamin E).

Questions?

OTC - QUESTIONS SECTION

877-787-7180

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label01.jpgLabel01.jpg

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02.jpgLabel02.jpg

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label03.jpgLabel03.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1045482menthol 1.5 % Topical CreamPSN1
1045482menthol 15 MG/ML Topical CreamSCD1
1045482menthol 1.5 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84573-515-04Real Time Pain Relief Foot125 g in 1 JARCREAM1251
84573-515-06Real Time Pain Relief Foot170 g in 1 JARCREAM1701
84573-515-08Real Time Pain Relief Foot226 g in 1 JARCREAM2261

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84573-515REAL TIME PAIN RELIEF FOOT (MENTHOL) CREAM [REAL TIME PRODUCTS INC.]1Current NDC, 3 package rows20240725_29c8e06d-9b29-44f9-ac21-9160d06475cb.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84573-51584573-515-04, 84573-515-06, 84573-515-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CERESINQ1LS2UJO3AIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CHAMOMILEFGL3685T2XIACT
CORIANDER1OV56052IKIACT
EMU OIL344821WD61IACT
EUCALYPTUS OIL2R04ONI662IACT
GLYCERINPDC6A3C0OXIACT
ST. JOHN'S WORTUFH8805FKAIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
LANOLIN7EV65EAW6HIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
PETROLATUM4T6H12BN9UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 207T1F30V5YHIACT
POLYSORBATE 806OZP39ZG8HIACT
VITAMIN A81G40H8B0TIACT
SALIX ALBA BARK205MXS71H7IACT
SODIUM BORATE91MBZ8H3QOIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
STEARYL ALCOHOL2KR89I4H1YIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
MENTHOLL7T10EIP3AACTIB

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
Real Time Pain Relief FootMENTHOLReal Time Products Inc.29c8e06d-9b29-44f9-ac21-9160d06475cb2024-07-24WarningsExact identifier
ndc (package): 84573-515-08
ndc (package): 84573-515-06
ndc (package): 84573-515-04
ndc (product): 84573-515
ndc11 (package): 84573051508
ndc11 (package): 84573051504
ndc11 (package): 84573051506
spl id: 1dfa79de-8251-2efc-e063-6394a90ab5ac
spl set id: 29c8e06d-9b29-44f9-ac21-9160d06475cb

Reported adverse events (FAERS/openFDA)#

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