TruRelief RUBITON Rub It Where It Hurts

Manufacturer
Cosmetic Specialty Labs, Inc.
Effective date
2022-02-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:48:09

Label at a glance#

ProductTruRelief RUBITON Rub It Where It Hurts
Active ingredientMENTHOL
Label structure10 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 12 years: • apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 time daily Children 12 years or younger: ask a doctor typographical correction and effective date update

Label contents#

Full prescribing information#

Active Incredient

OTC - ACTIVE INGREDIENT SECTION

Menthol, 3.0%

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

OTC - WHEN USING SECTION

When using this prodcut•use only as directed •do not bandage tightly or use with heating pad •avoid contact with eyes or mucous membranes •do not apply to wounds or damaged skin

OTC - STOP USE SECTION

Stop use and ask a doctor if• 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 - KEEP OUT OF REACH OF CHILDREN SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:• apply generously to affected area • massage into painful area until thoroughly absorbed into skin • repeat as necessary, but no more than 4 time daily

Children 12 years or younger: ask a doctor

RECENT MAJOR CHANGES SECTION

typographical correction and effective date update

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Anthemis nobilis (Roman Chamomile), Arnica montana Flower Extract, Butylene Glycol, Calendula officinalis (Marigold), Caprylyl Glycol, Capsicum frutescens Fruit, Carbomer, Centaurea cyanus (Cornflower), Cetearyl Alcohol, Chamomilla recutita (Matricaria Chamomilla), Coriandrum sativum (Coriander) Fruit Oil, Emu Oil, Fragrance, Hamamelis virginiana (Witch Hazel) Bark/Leaf/Twig Extract, Hypericum perforatum (St. John's Wort), Methylsulfonylmethane, Phenoxyethanol, Purified Water, Salix alba (Willow) Bark Extract, SD Alcohol 40, Sorbitol, Tetrasodium EDTA, Tilia cordata (Lime Tree), Triethanolamine.

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1442261menthol 3 % Topical CreamPSN1
1442261menthol 30 MG/ML Topical CreamSCD1
1442261menthol 3 % Topical CreamSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58133-451-042024-01-30C16284748780-11030e365-2dbf-111a-e063-dadaa90a10e2d7876228-8dd7-e3bd-e053-2a95a90a7925

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58133-451-04TruRelief RUBITON Rub It Where It Hurts88 mL in 1 TUBECREAM881

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58133-451TRURELIEF RUBITON RUB IT WHERE IT HURTS (MENTHOL) CREAM [COSMETIC SPECIALTY LABS, INC.]1Legacy NDC, 1 package rows20220209_d7876228-8dd7-e3bd-e053-2a95a90a7925.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58133-45158133-451-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

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
d7875d8c-dbc2-0f31-e053-2a95a90a5030d7876228-8dd7-e3bd-e053-2a95a90a79252022-02-08WarningsExact identifier
spl id: d7875d8c-dbc2-0f31-e053-2a95a90a5030
spl set id: d7876228-8dd7-e3bd-e053-2a95a90a7925

Reported adverse events (FAERS/openFDA)#

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