FDA.reportPublic FDA data

Real Time Pain Relief MAXX

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2020-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:03:40

Label at a glance#

ProductReal Time Pain Relief MAXX Topical Analgesic
Active ingredientMENTHOL
Label structure9 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#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 1.5%

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

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

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

SPL UNCLASSIFIED SECTION

Distributed by: RTPR LLC, Edmond, OK 73012

PRINCIPAL DISPLAY PANEL - 120 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

4ozbottle4ozbottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1148429menthol 1.5 % Topical LotionPSN3
1148429menthol 15 MG/ML Topical LotionSCD3
1148429menthol 1.5 % Topical LotionSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-100-042024-01-30C16284748780-11030e365-03d4-111a-e063-dadaa90a10e2Real Time Pain Relief George Foreman Knockout Formula
58133-100-122024-01-30C16284748780-11030e365-03d4-111a-e063-dadaa90a10e2Real Time Pain Relief George Foreman Knockout Formula
58133-100-152024-01-30C16284748780-11030e365-03d4-111a-e063-dadaa90a10e2Real Time Pain Relief George Foreman Knockout Formula
58133-100-162024-01-30C16284748780-11030e365-03d4-111a-e063-dadaa90a10e2Real Time Pain Relief George Foreman Knockout Formula
58133-100-332024-01-30C16284748780-11030e365-03d4-111a-e063-dadaa90a10e2Real Time Pain Relief George Foreman Knockout Formula
58133-100-602024-01-30C16284748780-11030e365-03d4-111a-e063-dadaa90a10e2Real Time Pain Relief George Foreman Knockout Formula
58133-100-622024-01-30C16284748780-11030e365-03d4-111a-e063-dadaa90a10e2Real Time Pain Relief George Foreman Knockout Formula

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-100-04Real Time Pain Relief MAXXTopical Analgesic120 mL in 1 TUBELOTION1203
58133-100-12Real Time Pain Relief MAXXTopical Analgesic473 mL in 1 BOTTLE, PUMPLOTION4733
58133-100-15Real Time Pain Relief MAXXTopical Analgesic45 mL in 1 TUBELOTION453
58133-100-16Real Time Pain Relief MAXXTopical Analgesic473 mL in 1 BOTTLE, PUMPLOTION4733
58133-100-33Real Time Pain Relief MAXXTopical Analgesic97.5 mL in 1 TUBELOTION97.53
58133-100-60Real Time Pain Relief MAXXTopical Analgesic120 mL in 1 BOTTLE, PLASTICLOTION1203
58133-100-62Real Time Pain Relief MAXXTopical Analgesic354 mL in 1 BOTTLE, PLASTICLOTION3543

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-100REAL TIME PAIN RELIEF MAXX TOPICAL ANALGESIC (MENTHOL 1.5%) LOTION [COSMETIC SPECIALTY LABS, INC.]3Legacy NDC, 7 package rows20200211_6180d7e4-1bc5-ffc5-e053-2991aa0af1b9.zip

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-10058133-100-33, 58133-100-04, 58133-100-15, 58133-100-12, 58133-100-16, 58133-100-60, 58133-100-62

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
DIMETHYL SULFONE9H4PO4Z4FTIACT
HYPERICUM PERFORATUM FLOWERA6V4CUE7PVIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TRIETHANOLAMINE TRIS(DIHYDROGEN PHOSPHATE)36YHT392IDIACT
ALOE VERA LEAFZY81Z83H0XIACT
CHAMAEMELUM NOBILE FLOWERO2T154T6OGIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPSICUM00UK7646FGIACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208IACT
CENTAUREA CYANUS FLOWERQZ239038YCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CORIANDER OIL7626GC95E5IACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
EMU OIL344821WD61IACT
GLUCOSAMINE HYDROCHLORIDE750W5330FYIACT
HAMAMELIS VIRGINIANA TOPUDA30A2JJYIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SALIX ALBA BARK205MXS71H7IACT
ISOPROPYL ALCOHOLND2M416302IACT
SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW)H5BJH23Z9AIACT
SORBITOL506T60A25RIACT
TILIA X EUROPAEA FLOWERNHV2K1OUDHIACT
MENTHOLL7T10EIP3AACTIB
BUTYLENE GLYCOL3XUS85K0RAIACT
MENTHA PIPERITA LEAFA389O33LX6IACT
ANTHEMIS ARVENSIS FLOWERING TOP851IP1R9YKIACT

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
9e3f34ca-c973-6f54-e053-2a95a90a6c126180d7e4-1bc5-ffc5-e053-2991aa0af1b92020-02-10WarningsExact identifier
spl id: 9e3f34ca-c973-6f54-e053-2a95a90a6c12
spl set id: 6180d7e4-1bc5-ffc5-e053-2991aa0af1b9

Reported adverse events (FAERS/openFDA)#

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