FDA.reportPublic FDA data

Dakota Muscle Relief Roll-On

Manufacturer
LaShe Naturals, LLC
Effective date
2021-12-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:45:34

Label at a glance#

ProductDakota Muscle Relief Roll-On
Active ingredientMENTHOL, UNSPECIFIED FORM
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains associated with simple backache arthritis sprains joint pain bruises strains.

Dosage and administration

Adults / Children 12 years or older: Shake well before use, test for skin sensitivity Spray directly on affected area Apply externally up to a maximum of 3 to 4 times a day Do not rub.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol 6.0%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains associated with

  • simple backache
  • arthritis
  • sprains
  • joint pain
  • bruises
  • strains.

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes. If contact occurs, flush eyes with water immediately.

Flammable

SPL UNCLASSIFIED SECTION

Keep away from fire or flame.

OTC - WHEN USING SECTION

When using this product:

  • Use only as directed
  • Do not bandage or use with a heating pad
  • Do not apply to wounds or damaged skin
  • Discontinue use if irritation develops.

OTC - STOP USE SECTION

Stop use and ask your doctor if:

Condition worsens or if symptoms persist more than 7 days

  • redness is present
  • excessive irritation of the skin develops.

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 ingested get medical help immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults / Children 12 years or older:

  • Shake well before use, test for skin sensitivity
  • Spray directly on affected area
  • Apply externally up to a maximum of 3 to 4 times a day
  • Do not rub.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Clove Bud, Emu Oil, Eucalyptus Oil, Isopropyl Alcohol, Peppermint Oil, Water, White Camphor

SPL UNCLASSIFIED SECTION

Distributed by:
LaShe Naturals, LLC
405 West Main, Suite 5D, West Fargo, ND 58078

PRINCIPAL DISPLAY PANEL - 90 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dakota
MUSCLE RELIEF

FAST ALL NATURAL PAIN RELIEF

Temporary Relief From:

  • Arthritis
  • Joint Pain
  • Back Pain
  • Sprains
  • Muscle Aches
  • Cramps
  • Congestion
  • Insect Bites

FAST ACTING • NOT GREASY
PLEASANT SCENT

Roll-On Muscle Relief
3oz. (90ml.)

PRINCIPAL DISPLAY PANEL - 90 ml Bottle Label
PRINCIPAL DISPLAY PANEL - 90 ml Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71680-002-032025-01-30C16284748780-12cef2736-6373-d83d-e063-dadaa90ab31fDakota Muscle Relief Roll-On

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71680-002DAKOTA MUSCLE RELIEF ROLL-ON (MENTHOL, UNSPECIFIED FORM) SOLUTION [LASHE NATURALS, LLC]3Legacy NDC20211212_880d39d5-63ba-42c2-996a-78b835550524.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71680-00271680-002-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ISOPROPYL ALCOHOLND2M416302IACT
Water059QF0KO0RIACT
Peppermint OilAV092KU4JHIACT
Eucalyptus Oil2R04ONI662IACT
Camphor Oil, White26P3H26Z9XIACT
CLOVE OIL578389D6D0IACT
Emu Oil344821WD61IACT
Xanthan GumTTV12P4NEEIACT

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
143397ce-e7b9-4eb2-8fa2-6b2ce8f088af880d39d5-63ba-42c2-996a-78b8355505242021-12-08WarningsExact identifier
spl id: 143397ce-e7b9-4eb2-8fa2-6b2ce8f088af
spl set id: 880d39d5-63ba-42c2-996a-78b835550524

Reported adverse events (FAERS/openFDA)#

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