FDA.reportPublic FDA data

Real Time Pain Relief Sports Cream

Manufacturer
Cosmetic Specialty labs, Inc.
Effective date
2018-01-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:01

Label at a glance#

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

Indications and uses

Temporarily relieves minor pain associated with arthritis simple backache muscle strains sprains bruises

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 ask a doctor

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Menthol 0.5%

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
  • simple backache
  • muscle strains
  • sprains
  • bruises

WARNINGS

WARNINGS SECTION

for external use only

When using this product

SPL UNCLASSIFIED SECTION

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

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

children 12 years or younger

SPL UNCLASSIFIED SECTION

ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis (Marigold), Caprylyl Glycol, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria Chamomilla), Coriandrum Sativum (Coriander) Fruit Oil, Curcuma Longa (Turmeric) Extract, Cupressus sempervirens (Cypress) Fruit Extract, Emu Oil, Fragrance, Gaultheria procumbens (Wintergreen) Oil, Glycerin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Helichrysum Italicum Flower, Hypericum perforatum (St. John’s Wort), Jasminum Officianale (Jasmine) Flower Extract, Lavendula Angustifolia (Lavender) Oil, Magnesium Chloride, Methylsulfonylmethane, Myristica Fragrans (Nutmeg) Extract, Origanum Majorana (Marjoram) Leaf Extract, Phenoxyethanol, Purified Water, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1114454menthol 0.5 % Topical CreamPSN1
1114454menthol 5 MG/ML Topical CreamSCD1
1114454menthol 0.5 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-700-042024-01-30C16284748780-11030e365-612e-111a-e063-dadaa90a10e2Real Time Pain Relief Sports Cream
58133-700-122024-01-30C16284748780-11030e365-612e-111a-e063-dadaa90a10e2Real Time Pain Relief Sports Cream
58133-700-152024-01-30C16284748780-11030e365-612e-111a-e063-dadaa90a10e2Real Time Pain Relief Sports Cream
58133-700-402024-01-30C16284748780-11030e365-612e-111a-e063-dadaa90a10e2Real Time Pain Relief Sports Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-700-04Real Time Pain Relief Sports CreamTopical Analgesic120 mL in 1 BOTTLE, PUMPLOTION1201
58133-700-12Real Time Pain Relief Sports CreamTopical Analgesic345 mL in 1 BOTTLE, PUMPLOTION3451
58133-700-15Real Time Pain Relief Sports CreamTopical Analgesic45 mL in 1 TUBELOTION451
58133-700-40Real Time Pain Relief Sports CreamTopical Analgesic120 mL in 1 TUBELOTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-700REAL TIME PAIN RELIEF SPORTS CREAM TOPICAL ANALGESIC (MENTHOL 0.5%) LOTION [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 4 package rows20180108_61d18e02-8b44-7c40-e053-2991aa0afbd2.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-70058133-700-04, 58133-700-12, 58133-700-40, 58133-700-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CARBOMER 934Z135WT9208IACT
CENTAUREA CYANUS FLOWERQZ239038YCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CORIANDER OIL7626GC95E5IACT
MAGNESIUM CHLORIDE02F3473H9OIACT
EMU OIL344821WD61IACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
WATER059QF0KO0RIACT
SALIX ALBA BARK205MXS71H7IACT
SORBITOL506T60A25RIACT
TILIA X EUROPAEA FLOWERNHV2K1OUDHIACT
MENTHOLL7T10EIP3AACTIB
MYRISTICA FRAGRANS WHOLEMF7T8BM40AIACT
TETRASODIUM DIETHYLENETRIAMINEPENTAMETHYLENEPHOSPHONATEE6DVO371LCIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CURCUMA LONGA LEAFH2HC4RY52CIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
2-(DIPROPYLAMINO)ETHANOL0916206V9SIACT
HELICHRYSUM ITALICUM FLOWERP62Y550X24IACT
JASMINUM OFFICINALE FLOWER0Q8K841432IACT
LAVENDER OILZBP1YXW0H8IACT
ORIGANUM MAJORANAR40XM3HU5XIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ROSMARINUS OFFICINALIS FLOWERING TOP OILOXN0D3N28LIACT
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE)36YHT392IDIACT
HYPERICUM PERFORATUMXK4IUX8MNBIACT
ANTHEMIS ARVENSIS FLOWERING TOP851IP1R9YKIACT
CUPRESSUS SEMPERVIRENS LEAF OILM7QUY89S4OIACT
GAULTHERIA PROCUMBENS LEAF2125M16OWNIACT
GLYCERINPDC6A3C0OXIACT

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
61d18e02-8b45-7c40-e053-2991aa0afbd261d18e02-8b44-7c40-e053-2991aa0afbd22018-01-02WarningsExact identifier
spl id: 61d18e02-8b45-7c40-e053-2991aa0afbd2
spl set id: 61d18e02-8b44-7c40-e053-2991aa0afbd2

Reported adverse events (FAERS/openFDA)#

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