NUTURNA Arthritis Intensive Concentrate for Pain Relief and Recovery

Manufacturer
Nuturna International LLC
Effective date
2024-01-04
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:06:38

Label at a glance#

ProductNUTURNA Arthritis Intensive Concentrate for Pain Relief and Recovery
Active ingredientMENTHOL
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises and sprains.

Dosage and administration

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor. We recommend testing a small amount of cream on your skin first to check for skin reaction and comfort level, wait 15 minutes before applying to affected area if you are happy with the comfort level.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 3.70%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses:

INDICATIONS & USAGE SECTION

  • For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, strains, bruises and sprains.

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • On damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes. 
  • Do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • Rash or irritation develops and lasts.
  • Condition worsens, or if symptoms persist for more than 7 days or clear up and occurs again within a few days.

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.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 2 years of age: consult a doctor.
  • We recommend testing a small amount of cream on your skin first to check for skin reaction and comfort level, wait 15 minutes before applying to affected area if you are happy with the comfort level.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf(Aloe Vera Gel)Juice, Arnica Montana Flower Extract, Carbomer, Ilex Paraguariensis (Yerba Mate) Extract, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Oil, Methylisothiazolinone, Methylsulfonylmethane (MSM), Polysorbate-20, Tocopheryl Acetate (Vitamin E), Triethanolamine, FD & C Blue # 1.

Other information:

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Questions ?

OTC - QUESTIONS SECTION

customerservice@nuturna.com

Package Labeling:57g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Package Labeling:114g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Package Labeling:228g

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label3Label3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1655936menthol 3.7 % Topical CreamPSN6
1655936menthol 37 MG/ML Topical CreamSCD6
1655936menthol 3.7 % Topical CreamSY6

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81996-244-02NUTURNA Arthritis Intensive Concentrate for Pain Relief and Recovery57 g in 1 JARCREAM576
81996-244-04NUTURNA Arthritis Intensive Concentrate for Pain Relief and Recovery114 g in 1 JARCREAM1146
81996-244-08NUTURNA Arthritis Intensive Concentrate for Pain Relief and Recovery228 g in 1 JARCREAM2286

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81996-244NUTURNA ARTHRITIS INTENSIVE CONCENTRATE FOR PAIN RELIEF AND RECOVERY (MENTHOL) CREAM [NUTURNA INTERNATIONAL LLC]6Legacy NDC, 3 package rows20240105_46384348-d48c-485c-aaf0-75a0a688ca85.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81996-24481996-244-02, 81996-244-04, 81996-244-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 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
58cd0eb9-070c-de5d-e063-6394a90a330946384348-d48c-485c-aaf0-75a0a688ca852026-08-11WarningsExact identifier
spl set id: 46384348-d48c-485c-aaf0-75a0a688ca85

Reported adverse events (FAERS/openFDA)#

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