FDA.reportPublic FDA data

Real Time Pain Relief Cream

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2017-12-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:07

Label at a glance#

ProductReal Time Pain Relief Cream
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

temporarily relieves minor pain associated with: arthritis simple backache muscle strains sprains bruises cramps

Dosage and administration

​adults and children over 2 years: apply generously to affected area massage into painful area until thoroughly 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 1.25%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves minor pain associated with:

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

WARNINGS SECTION

for external use only

When using this product

OTC - WHEN USING SECTION

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

Stop use and ask a 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
  • redness is present
  • irritation develops

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

​adults and children over 2 years:

  • apply generously to affected area
  • massage into painful area until thoroughly 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

Aloe Barbadensis Leaf, Anthemis nobilis Extract, Arnica Montana Flower Extract, Butylene Glycol, Calendula officianlis Extract, Caprylyl Glycol, Capsicum Frutescens Fruit, Carbomer, Centaurea cyanus Extract, Cetearyl Alcohol, Cetyl Alcohol, Coriandrum Sativum (Coriander) Fruit Oil, Diazolidinyl Urea, Emu Oil, Fragrance, Glucosamine HCI, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum Extract, Matricaria chamomilla Extract, Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix Alba (Willow) Bark Extract, SD Alcohol 40, Sodium Chondroitin Sulfate, Sorbitol, Tilia cordata Extract, Triethanolamine.

Package Label, Principal Display Panel and Drug Facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labelinglabeling

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240896menthol 1.25 % Topical LotionPSN1
240896menthol 12.5 MG/ML Topical LotionSCD1
240896menthol 1.25 % Topical LotionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-600-042024-01-30C16284748780-11030e365-6f36-111a-e063-dadaa90a10e2Real Time Pain Relief Cream
58133-600-072024-01-30C16284748780-11030e365-6f36-111a-e063-dadaa90a10e2Real Time Pain Relief Cream
58133-600-122024-01-30C16284748780-11030e365-6f36-111a-e063-dadaa90a10e2Real Time Pain Relief Cream
58133-600-152024-01-30C16284748780-11030e365-6f36-111a-e063-dadaa90a10e2Real Time Pain Relief Cream
58133-600-162024-01-30C16284748780-11030e365-6f36-111a-e063-dadaa90a10e2Real Time Pain Relief Cream
58133-600-332024-01-30C16284748780-11030e365-6f36-111a-e063-dadaa90a10e2Real Time Pain Relief Cream
58133-600-402024-01-30C16284748780-11030e365-6f36-111a-e063-dadaa90a10e2Real Time Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-600-04Real Time Pain Relief Cream120 mL in 1 BOTTLE, PUMPLOTION1201
58133-600-07Real Time Pain Relief Cream210 mL in 1 TUBELOTION2101
58133-600-12Real Time Pain Relief Cream354 mL in 1 BOTTLE, PUMPLOTION3541
58133-600-15Real Time Pain Relief Cream45 mL in 1 TUBELOTION451
58133-600-16Real Time Pain Relief Cream473 mL in 1 BOTTLE, PUMPLOTION4731
58133-600-33Real Time Pain Relief Cream98 mL in 1 TUBELOTION981
58133-600-40Real Time Pain Relief Cream120 mL in 1 TUBELOTION1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-600REAL TIME PAIN RELIEF CREAM (MENTHOL) LOTION [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 7 package rows20180112_617d4c4c-c540-f7a3-e053-2991aa0afc0e.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-60058133-600-15, 58133-600-07, 58133-600-04, 58133-600-12, 58133-600-16, 58133-600-40, 58133-600-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAPSICUM FRUTESCENS WHOLE6XJX33L87PIACT
ANTHEMIS ARVENSIS FLOWERING TOP851IP1R9YKIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CARBOMER 9404Q93RCW27EIACT
CORIANDRUM SATIVUM WHOLE740M8BF6EFIACT
WATER059QF0KO0RIACT
CALENDULA OFFICINALIS SEED OIL9JS8DS42SVIACT
CENTAUREA CYANUS FLOWERQZ239038YCIACT
MENTHOLL7T10EIP3AACTIB
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)H5BJH23Z9AIACT
HYPERICUM PERFORATUMXK4IUX8MNBIACT
PHENOXYETHANOLHIE492ZZ3TIACT
EMU OIL344821WD61IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
HAMAMELIS VIRGINIANA BARKIH3063S9MYIACT
SALIX ALBA BARK205MXS71H7IACT
TERT-BUTYL ALCOHOLMD83SFE959IACT
MATRICARIA CHAMOMILLA FLOWERING TOP OILSA8AR2W4ERIACT
3,4-METHYLENEDIOXYBENZYL METHYLSULFONE4W601CSX19IACT
CETYL ALCOHOL936JST6JCNIACT
CAPRYLYL GLYCOL00YIU5438UIACT
SORBITOL506T60A25RIACT
TILIA CORDATA FLOWERCFN6G1F6YKIACT
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE)36YHT392IDIACT

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
617d4c4c-c541-f7a3-e053-2991aa0afc0e617d4c4c-c540-f7a3-e053-2991aa0afc0e2017-12-29WarningsExact identifier
spl id: 617d4c4c-c541-f7a3-e053-2991aa0afc0e
spl set id: 617d4c4c-c540-f7a3-e053-2991aa0afc0e

Reported adverse events (FAERS/openFDA)#

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