FDA.reportPublic FDA data

NATUREPLEX EXTRA STRENGTH MUSCLE RUB

Manufacturer
Natureplex LLC
Effective date
2024-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:49:59

Label at a glance#

ProductNATUREPLEX EXTRA STRENGTH MUSCLE RUB
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure10 sections

Dosage and administration

Adults and children 2 years of age and older: apply to affected area up to 3 to 4 times daily Children under 2 years of age: consult a doctor

Storage and handling

store at 15 to 30°C (59 to 86°F). Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 2.5%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Use

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints associated with:

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes and mucous membranes.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin

When using this product

OTC - WHEN USING SECTION

  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • excessive irritation develops
  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

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: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: apply to affected area up to 3 to 4 times daily
  • Children under 2 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 15 to 30°C (59 to 86°F).
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

camphor, carbomer, DMDM hydantoin, isoceteth-20, isopropyl alcohol, PEG-40 hydrogenated castor oil, purified water, sodium hydroxide

PRINCIPAL DISPLAY PANEL - 42.5 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAST PENETRATING
PAIN RELIEF FROM:

  • Arthritis pain
  • Backache
  • Muscle pain
  • Joint pain
Principal Display Panel - 42.5 g Tube Carton
Principal Display Panel - 42.5 g Tube Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67234-076-01NATUREPLEX EXTRA STRENGTH MUSCLE RUB1 in 1 CARTONCREAM12
67234-076-01NATUREPLEX EXTRA STRENGTH MUSCLE RUB42.5 g in 1 TUBECREAM42.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67234-076NATUREPLEX EXTRA STRENGTH MUSCLE RUB (MENTHOL, UNSPECIFIED FORM) CREAM [NATUREPLEX LLC]2Legacy NDC, 2 package rows20250101_7f06cae7-e018-4408-8075-d32f6ba399de.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67234-07667234-076-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
DMDM HYDANTOINBYR0546TOWIACT
ISOCETETH-20O020065R7ZIACT
ISOPROPYL ALCOHOLND2M416302IACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
WATER059QF0KO0RIACT

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
d89858b4-0704-480b-b1ec-08e6ed469fc87f06cae7-e018-4408-8075-d32f6ba399de2024-12-31WarningsExact identifier
spl id: d89858b4-0704-480b-b1ec-08e6ed469fc8
spl set id: 7f06cae7-e018-4408-8075-d32f6ba399de

Reported adverse events (FAERS/openFDA)#

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