NUTRASTATE Soothing Relief Topical Gel

Manufacturer
NUTRASTATE, LLC | InSpec Solutions, LLC
Effective date
2021-07-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:41:18

Label at a glance#

ProductNUTRASTATE Soothing Relief Topical Gel
Active ingredientMENTHOL
Label structure11 sections

Indications and uses

Uses Temporary relief from minor aches and pains of muscle aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Menthol 4%............................................Topical Analgesic

Uses

OTC - PURPOSE SECTION

Uses Temporary relief from minor aches and pains of muscle aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains

INDICATIONS & USAGE SECTION

UsesTemporary relief from minor aches and pains of muscle aches and pains of muscles and joints associated with arthritis, simple backache, strains and sprains

Warnings

WARNINGS SECTION

Warnings

For external use only.


Flammable: Do not use while smoking or near heat or flame.

When using this product

OTC - WHEN USING SECTION

When using this product ● avoid contact with the eyes or mucous membranes ● do not apply to wounds or damaged skin ● do not apply to the irritate skin ● do not bandage ● wash hands after use with cool water ● do not use with heating pad or device

Stop use and ask a doctor if

OTC - STOP USE SECTION

Stop use and ask a doctor if ● condition worsens, or it symptoms persist for more than 7 days, or clear up and occur again within a few days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If accidentally ingested get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions ● 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 physician.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients Aloe Barbadensis Leaf Extract, Arctium Lappa Root (Burdock) Extract, Arnica Montana Flower Extract, Boswellia Carterii ResinExtract, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract, Camphor Carbomer, FD&C Blue #1, FD&C Yellow #5, Glycerin, Ilex Paraguariensis (Mate) Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis (Lemon Balm) Leaf Extract, Silica, Tocopheryl Acetate, Triethanolamine, Whole Hemp Extract (Isolate), Water.

Questions?

OTC - QUESTIONS SECTION

Questions? 888-253-0477

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gel LotionGel Lotion

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81178-002-082025-12-12C16284748780-1f386c649-cdd1-0266-e053-dadaa90a7c1ab4f56e20-338c-a0a5-e053-2995a90a0b6b
81178-002-082023-01-30C16284748780-1f386c649-cdd1-0266-e053-dadaa90a7c1ab4f56e20-338c-a0a5-e053-2995a90a0b6b

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81178-002NUTRASTATE SOOTHING RELIEF TOPICAL GEL (MENTHOL) GEL [NUTRASTATE, LLC]2Legacy NDC20210709_b4f56e20-338c-a0a5-e053-2995a90a0b6b.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81178-00281178-002-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 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
45c840b8-1b73-33de-e063-6394a90a809fb4f56e20-338c-a0a5-e053-2995a90a0b6b2025-12-12WarningsExact identifier
spl set id: b4f56e20-338c-a0a5-e053-2995a90a0b6b

Reported adverse events (FAERS/openFDA)#

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