FDA.reportPublic FDA data

Real Time Pain Relief Foot Cream

Manufacturer
Cosmetic Specialty labs, Inc.
Effective date
2018-01-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:03

Label at a glance#

ProductReal Time Pain Relief Foot Cream Topical Analgesic
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

Temporarily relieves minor pain associated with arthritis muscle strains sprains bruises cramps

Dosage and administration

apply generously to affected area massage into painful area until throughly absorbed into skin repeat as necessary, but no more than 4 times daily Children 2 years or younger:ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.5%

PURPOSE

OTC - PURPOSE SECTION

Topical analgesic

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.

USES

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain associated with

  • arthritis
  • muscle strains
  • sprains
  • bruises
  • cramps

WARNINGS

WARNINGS SECTION

for external use only

When using this product

SPL UNCLASSIFIED SECTION

  • use only as directed
  • do not bandage tightly or use with heating pad
  • avoid contact with eyes or mucus membranes
  • do not apply to wounds or damaged skin

Stop using and ask a doctor if

SPL UNCLASSIFIED SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If pregnant or breast-feeding

SPL UNCLASSIFIED SECTION

ask a health professional before use

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

adults and children over 2 years

SPL UNCLASSIFIED SECTION

  • apply generously to affected area
  • massage into painful area until throughly absorbed into skin
  • repeat as necessary, but no more than 4 times daily

Children 2 years or younger:ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Allantoin, Aloe barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Ascorbic Acid, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Eucalyptus globulus Leaf Oil, Hydrogenated Vegetable Oil, Hypericum perforatum (St. John’s Wort), Lactic Acid, Lanolin, Matricaria chamomilla (Chamomile), Melaleuca alternifolia (Tea Tree) Leaf Oil, Paraffin, Petrolatum, Phenoxyethanol, Polysorbate-20, Polysorbate-60, Purified Water, Retinyl Palmitate, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sodium Borate, Sorbitan Sesquioleate, Stearyl Alcohol, Tilia sylvestris (Lime Tree), Tocopheryl Acetate.

PRINCIPAL DISPLAY PANEL and DRUG FACTS

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-900-042024-01-30C16284748780-11030e365-595f-111a-e063-dadaa90a10e2Real Time Pain Relief Foot Cream
58133-900-082024-01-30C16284748780-11030e365-595f-111a-e063-dadaa90a10e2Real Time Pain Relief Foot Cream
58133-900-142024-01-30C16284748780-11030e365-595f-111a-e063-dadaa90a10e2Real Time Pain Relief Foot Cream
58133-900-162024-01-30C16284748780-11030e365-595f-111a-e063-dadaa90a10e2Real Time Pain Relief Foot Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-900-04Real Time Pain Relief Foot CreamTopical Analgesic125 g in 1 JARCREAM1251
58133-900-08Real Time Pain Relief Foot CreamTopical Analgesic227 g in 1 JARCREAM2271
58133-900-14Real Time Pain Relief Foot CreamTopical Analgesic40 g in 1 JARCREAM401
58133-900-16Real Time Pain Relief Foot CreamTopical Analgesic453 g in 1 JARCREAM4531

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-900REAL TIME PAIN RELIEF FOOT CREAM TOPICAL ANALGESIC (MENTHOL 1.5%) CREAM [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 4 package rows20180110_61e41c3f-b760-4b3d-e053-2991aa0a3248.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-90058133-900-04, 58133-900-14, 58133-900-08, 58133-900-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
TILIA X EUROPAEA FLOWERNHV2K1OUDHIACT
ALPHA-TOCOPHERYLOXYACETIC ACIDJW7FJR3ZLYIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT
POLYSORBATE 60CAL22UVI4MIACT
ALOE VERA LEAFZY81Z83H0XIACT
ALLANTOIN344S277G0ZIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
LACTIC ACID33X04XA5ATIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
LANOLIN7EV65EAW6HIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
CENTAUREA CYANUS FLOWERQZ239038YCIACT
CETYL ALCOHOL936JST6JCNIACT
CORIANDER OIL7626GC95E5IACT
POLYSORBATE 207T1F30V5YHIACT
EMU OIL344821WD61IACT
WATER059QF0KO0RIACT
SALIX ALBA BARK205MXS71H7IACT
MENTHOLL7T10EIP3AACTIB
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
HYDROGENATED COTTONSEED OILZ82Y2C65EAIACT
HYPERICUM PERFORATUMXK4IUX8MNBIACT
PHENOXYETHANOLHIE492ZZ3TIACT
RETINYL PROPIONATE32JK994WMCIACT
.ALPHA.-ISOBUTYLPHENETHYL ALCOHOL2SBL0E1I0NIACT
SODIUM BORATE91MBZ8H3QOIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
ISOSTEARYL ALCOHOLQ613OCQ44YIACT

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
61e41c3f-b761-4b3d-e053-2991aa0a324861e41c3f-b760-4b3d-e053-2991aa0a32482018-01-03WarningsExact identifier
spl id: 61e41c3f-b761-4b3d-e053-2991aa0a3248
spl set id: 61e41c3f-b760-4b3d-e053-2991aa0a3248

Reported adverse events (FAERS/openFDA)#

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