FDA.reportPublic FDA data

EXTRA STRENGTH JOINT AND MUSCLE RELIEF GEL

Manufacturer
Lifecure Rx Specialty Pharmacy
Effective date
2019-03-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:58:52

Label at a glance#

ProductEXTRA STRENGTH AND MUSCLE RELIEF 900 mg
Active ingredientMENTHOL, LIDOCAINE
Label structure11 sections

Indications and uses

Temporary relief of minor arthritis, backache, muscle and joint pain

Dosage and administration

• adults and children 12 and older: Apply 1 to 4 pumps to areas of pain and discomfort. Reapply as necessary using no more than 4 times daily. • children under the age of 12: Do not use, ask a doctor

Storage and handling

• Store at 20-35 deg C (68-77deg F).

Label contents#

Full prescribing information#

Uses

OTC - PURPOSE SECTION

Temporary relief of minor arthritis, backache, muscle and joint pain

Warnings

WARNINGS SECTION

For external use only
Allergy alert: If prone to allergic reaction to latex, consult a doctor before use. Symptoms may include: • rash • blisters • skin reddening
If a skin reaction occurs, stop use and seek medical help right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• adults and children 12 and older: Apply 1 to 4 pumps to areas of pain and discomfort. Reapply as necessary using no more than 4 times daily.
• children under the age of 12: Do not use, ask a doctor

When using this product:

INDICATIONS & USAGE SECTION

• Use only as directed • Avoid contact with eyes and mucous membranes • do not use with a heating pad • do not bandage tightly

• do not apply to wounds or damaged skin

Stop and ask doctor if

OTC - ASK DOCTOR SECTION

• condition worsens • symptoms last for more than 7 days • symptoms clear up and occur again within a few days • redness or irritation occurs

storage

STORAGE AND HANDLING SECTION

• Store at 20-35 deg C (68-77deg F).

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact poison control right away.

Active Ingredients & Purpose

OTC - ACTIVE INGREDIENT SECTION

Menthol 4%----------------- Analgesic

Lidocaine 3%--------------- Analgesic

Inactive Ingredient

INACTIVE INGREDIENT SECTION

bergamot oil, carbomer 940, caderwood oil, devil' claw extract, ethanol, geranium oil, Glydant Plus, hemp extract cannabidiol oil, horse chestnut seed extract, lavender oil, oleic acid, propylene glycol, purified water, soya photidylcholine, triethanolamine.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JOINT AND MUSCLE RELIEF GELJOINT AND MUSCLE RELIEF GEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JOINT AND MUSCLE RELIEF GELJOINT AND MUSCLE RELIEF GEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2119808lidocaine 3 % / menthol 4 % Topical GelPSN1
2119808lidocaine 0.03 MG/MG / menthol 0.04 MG/MG Topical GelSCD1
2119808lidocaine 3 % / menthol 4 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130728000002304GTIN-13: 0728000002304
EAN-13: 0728000002304
GTIN-12: 728000002304
UPC-A: 728000002304
GTIN storage (14 digits): 00728000002304		900-2.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72800-002-302021-01-29C16284748780-1ba0f9c33-43bf-a910-e053-dadaa90a0b85EXTRA STRENGTH JOINT AND MUSCLE RELIEF GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72800-002-30EXTRA STRENGTH AND MUSCLE RELIEF 900 mg30 mL in 1 BOTTLEGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72800-002EXTRA STRENGTH AND MUSCLE RELIEF 900 MG (MENTHOL AND LIDOCAINE) GEL [LIFECURE RX SPECIALTY PHARMACY]1Legacy NDC, 1 package rows20190318_dd8f849a-177f-4237-bd92-de1b17065c97.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72800-00272800-002-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
LIDOCAINE98PI200987ACTIB
BERGAMOT OIL39W1PKE3JIIACT
CARBOMER 934Z135WT9208IACT
JUNIPERUS VIRGINIANA OILPAD4FN7P2GIACT
HARPAGOPHYTUM PROCUMBENS ROOT1OYM338E89IACT
ALCOHOL3K9958V90MIACT
GERANIUM THUNBERGII FLOWERING TOP9IXM1668B6IACT
HEMPTD1MUT01Q7IACT
HORSE CHESTNUT3C18L6RJAZIACT
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
OLEIC ACID2UMI9U37CPIACT
1,2-DILINOLEOYL-SN-GLYCERO-3-PHOSPHOCHOLINE7L874P1M1OIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT

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
5c66709c-3e93-4cb6-8570-bb0890473d0fdd8f849a-177f-4237-bd92-de1b17065c972019-03-18WarningsExact identifier
spl id: 5c66709c-3e93-4cb6-8570-bb0890473d0f
spl set id: dd8f849a-177f-4237-bd92-de1b17065c97

Reported adverse events (FAERS/openFDA)#

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