FDA.reportPublic FDA data

Real Time Pain Relief Maxx Plus Topical Analgesic Lotion

Manufacturer
Real Time Products Inc.
Effective date
2024-11-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:36:56

Label at a glance#

ProductReal Time Pain Relief Maxx Plus Topical Analgesic
Active ingredientMENTHOL
Label structure12 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 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 1.9%

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

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 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.

Other Ingredients:

INACTIVE INGREDIENT SECTION

*Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Calendula Officinalis Extract, Cannabis Sativa (Hemp)Seed Oil, Caprylyl Glycol, Capsaicin, Centaurea Cyanus (Cornflower) Extract, Chamomilla Matricaria (Chamomile) Extract, Chondroitin Sulfate, Coriandrum Sativum (Coriander) Fruit Oil, Emu Oil, Glucosamine Sulfate, Glycerin, Hamamelis Virginiana (Witch Hazel), Hypericum Perforatum (St. John's Wort) Extract, C13-14 Isoparaffin, Laureth-7, Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polyacrylamide, Salix Alba (Willow) Bark Extract, SD-Alcohol 40B, Sorbitol, Tilia Cordata (Linden) Bark Extract. *Denotes certified organic ingredient.

Questions?

OTC - QUESTIONS SECTION

877-787-7180

Package Labelling: 88ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label.jpgOuter Label.jpg

Package Labelling: 120ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label02.jpgLabel02.jpg

Package Labelling: 147.8ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label03.jpgLabel03.jpg

Package Labelling: 210ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label04.jpgLabel04.jpg

Package Labelling: 354ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label05.jpgLabel05.jpg

Package Labelling: 473ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label06.jpgLabel06.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84573-547-03Real Time Pain Relief Maxx Plus Topical Analgesic88 mL in 1 TUBELOTION881
84573-547-04Real Time Pain Relief Maxx Plus Topical Analgesic120 mL in 1 TUBELOTION1201
84573-547-05Real Time Pain Relief Maxx Plus Topical Analgesic147.8 mL in 1 TUBELOTION147.81
84573-547-07Real Time Pain Relief Maxx Plus Topical Analgesic210 mL in 1 TUBELOTION2101
84573-547-12Real Time Pain Relief Maxx Plus Topical Analgesic354 mL in 1 BOTTLELOTION3541
84573-547-16Real Time Pain Relief Maxx Plus Topical Analgesic473 mL in 1 BOTTLELOTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84573-547REAL TIME PAIN RELIEF MAXX PLUS TOPICAL ANALGESIC (MENTHOL) LOTION [REAL TIME PRODUCTS INC.]1Current NDC, 6 package rows20241114_fc509a55-594d-4d44-87db-33286e937581.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84573-54784573-547-03, 84573-547-04, 84573-547-05, 84573-547-07, 84573-547-12, 84573-547-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
HEMPTD1MUT01Q7IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CAPSAICINS07O44R1ZMIACT
CHAMOMILEFGL3685T2XIACT
CORIANDER OIL7626GC95E5IACT
EMU OIL344821WD61IACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
WITCH HAZEL101I4J0U34IACT
ST. JOHN'S WORTUFH8805FKAIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
PEPPERMINT OILAV092KU4JHIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SALIX ALBA (WILLOW) BARK EXTRACT205MXS71H7IACT
SORBITOL506T60A25RIACT
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 Maxx Plus Topical AnalgesicMENTHOLReal Time Products Inc.fc509a55-594d-4d44-87db-33286e9375812024-11-12WarningsExact identifier
ndc (package): 84573-547-07
ndc (package): 84573-547-05
ndc (package): 84573-547-04
ndc (package): 84573-547-03
ndc (package): 84573-547-16
ndc (package): 84573-547-12
ndc (product): 84573-547
ndc11 (package): 84573054703
ndc11 (package): 84573054704
ndc11 (package): 84573054712
ndc11 (package): 84573054716
ndc11 (package): 84573054707
ndc11 (package): 84573054705
spl id: 26b61417-67ca-df12-e063-6394a90a79ef
spl set id: fc509a55-594d-4d44-87db-33286e937581

Reported adverse events (FAERS/openFDA)#

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